238 Results for

Regulatory Affairs Jobs in East Northport, NY

Jobs

Regulatory Affairs Specialist Joulé

Trumbull, CT

$30–$35 / hour

Skills — strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.

9 days ago

Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer Ingelheim

Ridgefield, CT

$170,000–$269,000 / year

If you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.

30+ days ago

Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals Inc

$128,600–$210,000 / year

Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.

30+ days ago

Regulatory Affairs Specialist Regulatory Affairs Specialist Lancesoft

Trumbull, CT

Skills —strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Manage workload, priority and performance of regulatory staff, in addition to providing development opportunities to build capability.

16 days ago

Regulatory Affairs Admin Asst Life's WORC

Garden City, New York

Excellent verbal & written communication skills, excellent organizational & time management skills, as well as excellent customer service skills. Assist with follow up on incident items needed from various departments to ensure incidents are completed/closed within the regulatory timeframe.

30+ days ago

Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer Ingelheim

Ridgefield, CT

$250,000–$394,000 / year

The Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships.

30+ days ago

Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals Inc

Remote

$157,200–$256,600 / year

Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.

30+ days ago

Regulatory Affairs Specialist Zobility

Trumbull, CT

Strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Work proactively with cross-functional teams to ensure product regulatory compliance and provide necessary regulatory documentation.

16 days ago

Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim

Ridgefield, CT

$20–$33 / hour

In the Regulatory Affairs Labeling Ops AI Innovation Co-Op role, your work will help modernize labeling operations through artificial intelligence, automation, and digital solutions—directly impacting how we deliver compliant, patient-centered labeling and regulatory content. This role is focused on utilizing artificial intelligence, automation tools, and digital solutions to modernize labeling operations workflows, drive greater accuracy, seamless system integration, and enhanced operational efficiency.

30+ days ago

Vice President, Food Safety, Quality & Regulatory Affairs DO & CO AG

Jamaica, NY

$200,000–$230,000 / year

The ideal candidate is a transformational leader with extensive experience in multi-site food manufacturing, airline catering, commissary, or high-volume food production environments and a proven ability to build world-class food safety programs that protect consumers, strengthen customer partnerships, and uphold the integrity of the DO & CO brand. DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to provide executive leadership for all food safety, quality assurance, regulatory compliance, sanitation, supplier quality, and product integrity initiatives across our North American operations.

16 days ago

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) CEFALY Technology

Darien, CT

Remote

A critical priority for this role will be optimizing and expanding the company's electronic Quality Management System (eQMS), conducting comprehensive assessments of quality documentation and system effectiveness, and driving sustainable process improvements across the organization. This role is being added to strengthen organizational quality and regulatory capabilities, reduce single-point dependency risk, improve QMS sustainability, and establish scalable systems supporting long-term growth and compliance excellence.

10 days ago

Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals Inc

TARRYTOWN, NY

$128,600–$210,000 / year

A typical day might include the following: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.

30+ days ago

Regulatory Affairs Specialist Globalchannelmanagement

Trumbull, CT

Strong communication skills, ability to manage projects with cross functional teams, proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), SAP experience helpful. Regulatory Affairs Specialist requires: 1-3 years experience in regulatory affairs field of Laundry and detergents or CPG products.

13 days ago

Pesticides Regulatory Affairs Specialist Globalchannelmanagement

Trumbull, Connecticut

Pesticides Regulatory Affairs Specialist needs 5 years of experience in pesticide product registration; or equivalent combination of education and experience, including preparation and submission of pesticide registration applications, product labels, offers-to-pay, data matrices, etc. Support FIFRA registrations for conventional pesticides including preparing, submitting and/or managing product applications.

13 days ago

Regulatory Affairs Specialist Elliquence

BALDWIN, NY

Full time

This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.

30+ days ago

Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals Inc

$205,000–$341,600 / year

The Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.

20 days ago

Regulatory Affairs Specialist Lancesoft

Trumbull, CT

Skills, experience and qualifications: At least 5 years of experience in pesticide product registration;or equivalent combination of education and experience, including preparation and submission of pesticide registration applications, product labels, offers-to-pay, data matrices, etc. Responsibilities: This is work in pesticide product registration and compliance requiring an entrepreneurial attitude, and enthusiasm for supporting business development and technical efforts supporting new end-use product registrations.

16 days ago

Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$200,000–$316,000 / year

Works with the Medical Strategy Team Leader, the US TAs, global medical, Commercial operations, Go-To-Market (GTM), and CDMA leaders to identify and leverage synergies throughout the product lifecycle and actively provide input into clinical development early asset planning, Commercial strategies to ensure the success of launches and timely execution of prioritized evidence generation initiatives. Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding bronchiectasis products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics).

30+ days ago

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$200,000–$316,000 / year

Works with the Medical Strategy Team Leader, the US TAs, global medical, Commercial operations, Go-To-Market (GTM), and CDMA leaders to identify and leverage synergies throughout the product lifecycle and actively provide input into clinical development early asset planning, Commercial strategies to ensure the success of launches and timely execution of prioritized evidence generation initiatives. Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding pulmonary fibrosis products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics).

30+ days ago

Sr AD / Director, Medical Affairs Strategy - ILD (On-site/Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$200,000–$316,000 / year

Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regardingTA products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics). Serves as a key representative in strategic discussions with TAs and CDMA Leadership regarding TA products to maximize business opportunities from a medical perspective, identify risks, assess the competitive landscape, and ensure appropriate collaboration occur with various business functions.

30+ days ago

Associate Director, Faculty Affairs Yale University

New Haven, CT

$90,000–$165,750 / year

This role serves as the central administrative leader for faculty affairs and the respective teams supporting all faculty, residents, fellows, students, postdoctoral/postgraduate trainees, and international students and visiting students and faculty while ensuring alignment with School of Medicine and University policies. Ensure high quality delivery of administrative services by providers outside the department, including human resources, information technology, procurement, student services, post-doctoral affairs and faculty affairs.

30+ days ago

Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$250,000–$394,000 / year

Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding bronchiectasis products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics). In doing so, this individual will play a key role with corporate stakeholders, the US cross-functional partners, and the US Launch Teams in leading the co-creation of aligned strategic medical launch readiness; and work closely with the clinical development leads to ensure the successful integration of the US Medical insights and efforts where applicable.

30+ days ago

Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

$250,000–$394,000 / year

Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding pulmonary fibrosis products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics). In doing so, this individual will play a key role with corporate stakeholders, the US cross-functional partners, and the US Launch Teams in leading the co-creation of aligned strategic medical launch readiness; and work closely with the clinical development leads to ensure the successful integration of the US Medical insights and efforts where applicable.

30+ days ago

Director, Medical Affairs Strategy (Oncology) Boehringer Ingelheim International GmbH

Ridgefield, CT

$250,000–$394,000 / year

Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding oncology products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics). In doing so, this individual will play a key role with corporate stakeholders, the US cross-functional partners, and the US Launch Teams in leading the co-creation of aligned strategic medical launch readiness; and work closely with the clinical development leads to ensure the successful integration of the US Medical insights and efforts where applicable.

30+ days ago

Director, Medical Affairs Strategy Team Member (CardioRenal) (Hybrid) Boehringer Ingelheim International GmbH

Ridgefield, CT

Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding [X - TA] products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics). In doing so, this individual will play a key role with corporate stakeholders, the US cross-functional partners, and the US Launch Teams in leading the co-creation of aligned strategic medical launch readiness; and work closely with the clinical development leads to ensure the successful integration of the US Medical insights and efforts where applicable.

7 days ago

YSN Sr. Director of Clinical Affairs and Partnerships Yale University

Orange, CT

$124,000–$206,500 / year

Working collaboratively with senior leadership across Yale University, Yale School of Nursing, Yale New Haven Health System, and external healthcare organizations, the Senior Director develops and executes strategies that strengthen clinical education capacity, workforce development, faculty practice initiatives, and innovative models of academic-clinical integration. The Senior Director of Clinical Affairs and Partnerships provides strategic leadership for Yale School of Nursing's clinical education enterprise and serves as the principal administrative leader responsible for advancing academic-practice partnerships across Yale School of Nursing and Yale New Haven Health System.

3 days ago

Vice Dean of Academic Affairs, Lewyt College of Veterinary Medicine Long Island University

$220,000–$230,000 / year

Oversee agreements and collaborations with affiliates, partners, and other institutions Support the Office of Assessment Develop and manage assigned budgets Collaborates with Human Resources in faculty counseling and management of faculty grievance and appeals processes in alignment with Long Island University, Lewyt College of Veterinary Medicine mission areas. Vice Dean of Academic Affairs, Lewyt College of Veterinary MedicineVice Dean of Academic Affairs, Lewyt College of Veterinary Medicine No. 4526 Long Island University Brookville, New York Dean - Veterinary Medicine Posted Jan 23, 2026 $220,000 - $230,000.

30+ days ago

Senior Medical Director, Medical Affairs, MASH Regeneron Pharmaceuticals Inc

$333,300–$450,900 / year

This role might be for you if: • Must have an MD or MD equivalent with a preference for specialized fellowship training in Gastroenterology or Hepatology • 5 years of related industry experience in global or US medical affairs • Solid background and experience in drug development and life-cycle management • Experience with working in an alliance setting strongly preferred • Ability to lead technical and business discussions internally and externally and explain scientific/medical concepts to all levels • Ability to cultivate and maintain relationships with leading medical/scientific experts in the relevant fields • Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key opinion leaders • Strong leadership and management skills • Attention to detail in analyses, deliverables, and communications • Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management • A proactive self-starter who can lead work and manage others independently, with the ability to see the next step and take actions without prompting • Ability to juggle multiple projects • Thorough understanding of the healthcare environment including all external stakeholders. A typical day in this role might look like: • Provides visionary leadership in the development, execution, and continuous refinement of medical strategy and tactics for assigned assets, ensuring alignment with corporate and global objectives.

30+ days ago

Executive Director, Medical Affairs Celldex Therapeutics Inc

$233,631–$303,417 / year

Advanced scientific degree required (MD, PhD, PharmD or equivalent) 10-15+ years of combined clinical and/or biopharma experience, including Medical Affairs leadership in Immunology, Allergy, and/or Dermatology; launch experience strongly preferred Prior people management (direct reports) and matrix leadership across Field Medical (MSLs) and in‑house medical teams Proven track record leading publications/scientific communications programs and compliant data dissemination Exceptional scientific acumen and communication; ability to translate complex data for clinical, regulatory, commercial, and access stakeholders Strength in publication strategy/execution, KOL development, advisory board design, and congress/symposia strategy and execution Omni‑channel mindset with facility applying insights/analytics to optimize medical impact High integrity and strong judgment in a multi‑functional matrix; skilled in prioritization, budgeting, and vendor management Willingness to travel ~25-30% for priority engagements and congresses. Therapeutic area medical affairs strategy and planning Develop Medical Affairs strategies and plans focused on scientific communications and engagements with medical community to build Celldex presence and capabilities in Allergy and Dermatology Lead a team of Medical Affairs specialists to develop a strategically and commercially aligned scientific engagement and communication strategy for key immunology assets in Allergy and Dermatology therapeutic areas Provide disease‑area subject matter expertise on behalf of Medical Affairs to cross-functional partners, including Commercial (Marketing, Value and Access), R&D (clinical development, translational medicine, medical safety) to inform study designs, labels, and postmarketing commitments.

30+ days ago

Senior Medical Affairs Strategy and Operations Specialist HealthCare Partners, MSO

Garden City, NY

$80,000–$110,000 / year

The Manager plays a critical role in facilitating leadership meetings, maintaining physician schedules, tracking strategic initiatives, preparing executive-level communications, and ensuring timely follow-through on organizational commitments. Position Summary: The Senior Medical Affairs Strategy & Operations Specialist serves as a key operational partner to the Chief Medical Affairs Officer, providing administrative, project management, and strategic execution support across the Medical Affairs division.

29 days ago

Government Affairs Manager Coastal Wave Recruiting

Stamford, CT

$125,000–$150,000

This is a high-impact opportunity for a government affairs leader who can balance strategic thinking with hands-on execution to influence public policy outcomes and protect long-term business interests. Our client, a global consumer products company, is seeking a Government Affairs Manager to lead the development and execution of a comprehensive government affairs strategy aligned with corporate goals and priorities.

30+ days ago

Director, Influencer Marketing (Public Affairs) Orchestra

Washington, New York

$110,000–$125,000 / year

We lead integrated campaigns across media, stakeholder engagement, advocacy, research and paid media, coordinating seamlessly across internal teams and external partners to drive outcomes for clients across healthcare, nonprofits, technology, land use, education, infrastructure and other sectors. You will collaborate across public affairs, PR, digital, content, paid media and community engagement teams to build integrated programs that connect online engagement with real-world impact, including public sentiment, stakeholder alignment and policy outcomes.

30+ days ago

Athletic Student Affairs Coordinator Irvington Board Of Education

Irvington, NY

If you have not previously applied to the Irvington School District using our Applitrack system, please use the following URL, create an account and apply for the position you are seeking: New Applicants https://www.applitrack.com/irvington/onlineapp/_application.aspx?starting=true. Interested candidates should apply and utilize the Irvington Board of Education Applitrack system as follows: If you have previously applied to the Irvington School District using our Applitrack system, please use the following URL and apply for the new position you are seeking: Continue/Modify an Existing Application.

15 days ago

Principal Scientist - Clinical and Scientist Affairs Estee Lauder Inc

Melville, NY

$110,000–$125,000 / year

The company's products are sold in approximately 150 countries and territories under brand names including: Estée Lauder, Aramis, Clinique, Lab Series, Origins, M·A·C, La Mer, Bobbi Brown Cosmetics, Aveda, Jo Malone London, Bumble and bumble, Darphin Paris, TOM FORD, Smashbox, AERIN Beauty, Le Labo, Editions de Parfums Frédéric Malle, GLAMGLOW, KILIAN PARIS, Too Faced, Dr. Jart+, the DECIEM family of brands, including The Ordinary and NIOD, and BALMAIN Beauty. This individual will play a critical role in translating marketing consumer concepts into actionable and scientifically supportable data, and also translating complex scientific data into compelling product stories, ensuring scientific credibility while aligning with brand strategy and consumer expectations.

30+ days ago

SENIOR REGULATORY CONSULTANT Montefiore Medical Center

$72,000–$90,000 / year

Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. The Senior Regulatory Compliance Coordinator will act as a mentor to junior staff- providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.

30+ days ago

Associate Director, Medical Affairs-Strategic Business Planning & Execution, Regeneron Pharmaceuticals Inc

$157,200–$256,600 / year

Build our future together: The Associate Director, Medical Affairs Strategic Business Planning & Execution provides project management support to the Global Medical Affairs Head and Medical Directors within our Neurology Franchise. Provide project-related process support for implementation and execution of publication and communication plans, advisory boards, expert consultations, steering committees and management of vendors.

20 days ago

Associate Director, Regulatory Submission Project Management Regeneron Pharmaceuticals Inc

$157,200–$256,600 / year

Provides strategic oversight and leadership across therapeutic area(s), directing team members responsible for project managing regulatory milestones such as pre-IND or Scientific Advice, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, and BLA annual reports; accountable for functional quality and consistency across the portfolio. Serves as the senior escalation point and strategic advisor for team members and cross-functional groups, resolving complex issues related to timelines, submission documents, or regulatory matters impacting the timeliness or quality of submissions; establishes best practices and process improvements to enhance functional effectiveness.

19 days ago

Director of Regulatory and Patient Safety Stony Brook University

Stony Brook, NY

$142,800–$203,597 / year

2602444'',''2602444'',''TH Senior Staff Associate'',''TH Senior Staff Associate'',''Clinical Management'',''Clinical Management'',''US-NY-Stony Brook'',''US-NY-Stony Brook'',''JC Continued Readiness'',''JC Continued Readiness'',''Full-time'',''Full-time'',''Day Shift'',''Day Shift'',''8:30-5'',''8:30-5'',''Sat, Sun'',''Sat, Sun'',''Jul 2, 2026'',''Jul 2, 2026'',''Oct 1, 2026, 3:59:00 AM'',''Oct 1, 2026, 3:59:00 AM'',''142800 - 203597'',''142800 - 203597'','''','''',''SL5'',''SL5'',''Stony Brook University Hospital'',''Stony Brook University Hospital'',''false'',''736662'',''736662'',''true'',''736662'',''false'',''Submission for the position: Director of Regulatory and Patient Safety - (Job Number: 2602444)'',''false'',''736662'',''false'',''true''. The department will utilize the Director''s expertise to help prioritize projects, to develop detailed project plans for major safety & regulatory initiatives, assist other members of the department in planning projects, and assure a structured, well-planned approach for successful outcomes & project completion.

13 days ago

Senior Director Global Regulatory Lead - Oncology Eli Lilly and Co

Stamford, CT

$169,500–$248,600 / year

Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the program's value proposition, workflow, product labeling, risk management, and issues management.

9 days ago

Senior Manager, Medical Affairs-Classical Hematolog Regeneron Pharmaceuticals Inc

$150,500–$245,500 / year

As a Senior Manager, Medical Affairs -Classic Hematology you will serve as a scientific and strategic resource leading the execution of our medical plans across bleeding and clotting disorders. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

30+ days ago

Regulatory Incident Reporting Analyst BetMGM

Bridgeport, CT

$64,000–$80,500 / year

This position is responsible for assisting in the investigation, drafting, and submission of incident reports concerning regulatory violations and instances of non-compliance, and for supporting the Company's efforts to ensure that its online iGaming platform, online Sportsbook, and retail Sportsbook operations remain compliant with relevant state regulations, regulatory directives, and land-based sportsbook obligations in each jurisdiction. The Regulatory Incident Reporting Analyst will work under the direction and supervision of the Senior Manager of Compliance and Incident Reporting, and will partner closely with the Senior Analyst, Regulatory Incident Reporting in the day-to-day execution of incident intake, investigation, drafting, and cross-jurisdictional fine and warning tracking workstreams.

Today

Senior Counsel, Regulatory Philip Morris International Inc

$202,400–$253,000 / year

About the role: The Senior Counsel, Regulatory provides pragmatic, solutions‑oriented legal counsel to support PMI's U.S. business by enabling regulatory‑compliant decision‑making across product strategy, data generation, commercialization, and innovation. The U.S. Food and Drug Administration has authorized versions of PMI's IQOS electronically heated tobacco devices and Swedish Match's General snus as Modified Risk Tobacco Products and renewal applications for these products are presently pending before the FDA.

30+ days ago

CMC Regulatory Data Science Co-Op (Hybrid) Boehringer Ingelheim

Ridgefield, CT

$20–$33 / hour

This includes evaluating data/databases managed by the Regulatory Affairs team, identifying solutions to simplify and automate data management, and building platforms for data management in alignment with Boehringer Ingelheim’s digitial innovation initiative. Boehringer Ingelheim is currently seeking a talented and innovative Data Science co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility.

30+ days ago

Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu Ltd

$144,600–$265,100 / year

Candidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.

30+ days ago

Sr. Manager, Regulatory & Compliance Reporting Philip Morris International U.S.

Stamford, CT

Full time

10+ years of progressive experience in regulatory reporting, excise/compliance operations, licensing, or regulatory tax operations, 5+ years of experience working in a highly regulated nicotine/tobacco environment (smokeless tobacco, modern oral nicotine pouches, heated tobacco, ENDS, or adjacent regulated consumer goods). Position Overview: The Senior Manager, Regulatory & Compliance Reporting leads U.S. federal and state tobacco/nicotine regulatory reporting and the full lifecycle of tax-related licensing and permits for a multi-entity, multi-site smoke-free and smokeless portfolio (e.g., nicotine pouches, traditional smokeless tobacco, heated tobacco).

30+ days ago

Digital Assets Regulatory Management Senior Consultant Deloitte Touche Tohmatsu Ltd

$119,000–$218,300 / year

Successful candidates will demonstrate an aptitude for complex problem-solving and analytical skills and the ability to communicate complex ideas clearly and persuasively across a variety of strategic, operational, technological, and risk management matters. Candidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations.

30+ days ago

Sr. Regulatory Manager UnitedHealth Group Inc

Westbury, NY

$91,700–$163,700 / year

The fraudulent LinkedIn messages and emails, which do not originate from any Executives LinkedIn account or of UnitedHealth Group's email domains, or those of any of its operating divisions, supposedly conducts an interview via a Zoom meeting, offers a work from home job at Optum, emails an application, sends a fake check by next day delivery through USPS and asks recipients to pay a vendor a large dollar amount. Prepare and maintain site Study binders; distribute for signatures and collect updated FDA 1572, Financial Disclosure Forms, Delegation of Authority Logs, and Training Logs.

2 days ago

Regulatory Compliance Specialist Evolution AB

Fairfield, CT

$65,000–$75,000 / year

Our live services, which allow licensees' players on desktop, tablet and smartphone to play Live Casino games at real tables and with real dealers, have won multiple industry awards, including 'Live Casino Supplier of the Year' at the EGR B2B Awards for eleven consecutive years and 'Casino Content Provider of the Year' in the 2019 EGR North America Awards. Evolution is the world´s leading provider of video-streamed Live Casino solutions and Slots, delivering best-in-class 'as real as it gets' live dealer gaming to our licensees including many of the world´s best known gaming brands.

30+ days ago

Sr. Quality Assurance Manager Prestige Consumer Healthcare Inc

$150,000–$175,000 / year

Success in this position requires strong cross-functional collaboration with internal stakeholders, including Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics, as well as the ability to influence quality outcomes across a network of third-party manufacturing partners. Evaluate the effectiveness of contract manufacturing partners quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contract manufacturing partners response adequacy and timeliness; determining system improvements.

24 days ago

Sr. Quality Assurance Manager Prestige Brands

Tarrytown, NY

Full time

22 days ago

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Regulatory Affairs Jobs in East Northport, NY

Regulatory Affairs Specialist Joulé

Senior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer Ingelheim

Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals Inc

Regulatory Affairs Specialist Regulatory Affairs Specialist Lancesoft

Regulatory Affairs Admin Asst Life's WORC

Executive Director, Regulatory Affairs, Advertising and Promotion Boehringer Ingelheim

Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals Inc

Regulatory Affairs Specialist Zobility

Regulatory Affairs Labeling Operations AI Innovation Co-op Boehringer Ingelheim

Vice President, Food Safety, Quality & Regulatory Affairs DO & CO AG

Director, Quality Systems & Regulatory Affairs (Remote - East Coast) CEFALY Technology

Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals Inc

Regulatory Affairs Specialist Globalchannelmanagement

Pesticides Regulatory Affairs Specialist Globalchannelmanagement

Regulatory Affairs Specialist Elliquence

Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals Inc

Regulatory Affairs Specialist Lancesoft

Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid) Boehringer Ingelheim International GmbH

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid) Boehringer Ingelheim International GmbH

Sr AD / Director, Medical Affairs Strategy - ILD (On-site/Hybrid) Boehringer Ingelheim International GmbH

Associate Director, Faculty Affairs Yale University

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