Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
NewRegulatory Affairs Senior Associate electroCore IncRegulatory Affairs Senior AssociateRockaway, NJThe position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post-market and vigilance obligations, and partners cross-functionally to ensure compliant, timely execution of business objectives. • Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
NewTalent Acquisition Specialist Vaco LLCTalent Acquisition SpecialistNew York, NY$35–$41This position will primarily support hiring for Resource Development, Marketing, and Communications teams, including roles within Development/Fundraising, Public Affairs, Corporate Communications, and Marketing & Communications. Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
NewAssociate Director, US Brand Marketing CSL SeqirusAssociate Director, US Brand MarketingSummit, NJ$180,000–$205,000With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
NewTransactional Construction Associate Attorney JobotTransactional Construction Associate AttorneyNew York, NY$180,000–$350,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. We are a leading AM 100 Law Firm specializing in corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs and employing some of the best and brightest attorneys.
NewDirector, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Associate Director Corporate Communications JouléAssociate Director Corporate CommunicationsParsippany, NJ$135,000–$170,000 / yearJoin a growing biopharmaceutical organization where communications plays a critical role in shaping corporate reputation, supporting key business milestones, and translating complex science into meaningful stories. This is an opportunity to work closely with executive leadership and cross-functional teams to drive both external and internal communications initiatives across a fast-paced, highly visible environment.
NewDirector Medical Monitor JouléDirector Medical MonitorParsippany, NJ$210,000–$335,000 / yearServe as the primary medical contact for investigators and study sites regarding protocol-related medical questions, including subject eligibility and enrollment guidance. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewSr. Manager, Medical Review - Contract TalentBurst, Inc.Sr. Manager, Medical Review - ContractPlainsboro Township, NJRemote$38–$40 / hourOther notable details about the environment from the hiring manager about this role: Role works cross-functionally with multiple internal stakeholders/partners (i.e. regulatory review, legal, ethics, Medical affairs, commercial). • For designated therapeutic area of responsibility, attends, advises, and approves in review meetings as the lead Medical Reviewer for promotional review.
NewQuality Assurance Data Reviewer AtriumQuality Assurance Data ReviewerCranbury, NJ$31–$35 / hourRequired Experience/Skills for the Quality Assurance Data Reviewer: 3-5 years of Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review experience within a pharmaceutical, biotechnology, or other regulated life sciences environment. Evaluate Change Controls, Deviations, Laboratory Investigation Reports (LIRs), OOS, OOT, and COT events to ensure appropriate root cause determination and quality impact assessments.
NewQA Data Review & Compliance Specialist AtriumQA Data Review & Compliance SpecialistSouth Brunswick, NJ$31–$35 / hourEvaluate deviations, investigations, change controls, out-of-specification (OOS) and out-of-trend (OOT) events, and CAPA activities, including root cause analysis and quality impact assessments. Required Experience/Skills for the QA Data Review & Compliance Specialist: 3 - 5 years of experience in Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review within a pharmaceutical, biotechnology, or regulated life sciences environment.
Analytical Science Manager JouléAnalytical Science ManagerParsippany, NJ$100,000–$135,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
Medical Science Director (Mountain Plains) JouléMedical Science Director (Mountain Plains)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
Medical Science Director (New England Region) JouléMedical Science Director (New England Region)Parsippany, NJRemote$200,000–$235,000 / yearA field-based Medical Science Director will support Medical Affairs through compliant scientific exchange, insight gathering, and cross-functional collaboration across oncology and related therapeutic areas (infectious disease, nephrology, acute/critical care). This role partners with HCPs/KOLs, pharmacy leaders, and institutional stakeholders across inpatient/outpatient settings to support medical strategy, evidence generation initiatives, and scientific engagement (congresses, advisory boards, education).
NewMedical Science Director (Carolinas Region) JouléMedical Science Director (Carolinas Region)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
Medical Science Director (Ohio Valley) JouléMedical Science Director (Ohio Valley)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
Medical Science Director (Mid-Atlantic Region) JouléMedical Science Director (Mid-Atlantic Region)Parsippany, NJRemote$200,000–$240,000 / yearThis role serves as a clinical and scientific resource, facilitating evidence-based discussions, gathering medical insights, supporting clinical research initiatives, and collaborating cross-functionally to help inform medical strategy, education, and patient care. The Medical Science Director is a field-based medical affairs professional responsible for building scientific relationships with healthcare providers, key opinion leaders, and healthcare systems across oncology and related specialty therapeutic areas.
Research & Development, Scientist 2 YANTRAN LLCResearch & Development, Scientist 2Summit, NJ$30–$35 / yearFull timeWork closely with cross-functional teams, including other R&D functions, Commercial Marketing, Quality Assurance, Regulatory Affairs, and Manufacturing, to achieve project goals. Prepare and maintain detailed documentation for product development processes, including experimental protocols, and technical reports in compliance with Good Documentation Practices (GDP).
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
NewRegulatory Affairs Associate I The Fountain Group LLCRegulatory Affairs Associate IClark, NJBy applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Support regulatory inquiries related to hazard communication, transportation classification, waste management, and chemical inventories.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJThis role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Regulatory Affairs Associate II LanceSoft IncRegulatory Affairs Associate IIPrinceton, NJFull timeMajor Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Skills & Knowledge: Proficient in computer entry, Word, Excel, Powerpoint and internet use.
Regulatory Affairs Associate II Apidel TechnologiesRegulatory Affairs Associate IIPrinceton, NJContractorEnsures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking.
Program Development Analyst (Regulatory Affairs Associate) Actalent IncProgram Development Analyst (Regulatory Affairs Associate)New Brunswick, NJRemote$35–$40 / hourThis position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
NewSenior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionWarren, NJ$150,500–$245,500 / yearHelp 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 minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Associate Director, Regulatory Affairs Advertising & Promotion Compliance Kyowa Kirin Pharmaceutical Research IncAssociate Director, Regulatory Affairs Advertising & Promotion CompliancePrinceton, NJKyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz Group AGAssociate Director, Regulatory Affairs - Biosimilars (US)Princeton, NJ$145,600–$279,400 / yearp>With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Regulatory Affairs Associate Director, Globalization Becton Dickinson and CoRegulatory Affairs Associate Director, GlobalizationFranklin Lakes, NJ$183,800–$294,100 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make thorough regulatory assessments demonstrating the ability to solve difficult problems and create effective and innovative solutions. Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson and CoRegulatory Affairs Senior Director, Project Management ExcellenceFranklin Lakes, NJ$230,300–$368,500 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
Regulatory Affairs Intern Phibro Animal Health CorpRegulatory Affairs InternTeaneck, NJp>Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.
Associate Director, Regulatory Affairs Advertising & Promotions Tris Pharma IncAssociate Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$180,000–$225,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
Regulatory Affairs Associate SGS SARegulatory Affairs AssociateNJ$62,000–$75,000 / yearWith over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services. For C&H: Knowledge / experience in cosmetics, personal care or household care related testing services (microbiological, chemical, etc.) desirable (Preferred).
Senior Associate, Regulatory Affairs (US) BeOne Medicines AGSenior Associate, Regulatory Affairs (US)NY$40.91–$52.91 / hourAssist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
Senior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Senior Analyst, Regulatory Affairs Oscar Health IncSenior Analyst, Regulatory AffairsNYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Senior Manager, Regulatory Affairs Quidelortho CorpSenior Manager, Regulatory AffairsNJRemoteThis position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL The Responsibilities Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsNJ$255,800–$402,700 / year10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
Director, Regulatory Affairs Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Regulatory Affairs Manager Hybrid Spectrum VascularRegulatory Affairs Manager HybridBridgewater, NJRole Description: The Regulatory Affairs Manager is a seasoned professional responsible for contributing to and implementing regulatory strategies and tactics for the Company with a focus on achieving product registrations as well as assuring compliance to product claims for all current and new product submissions in the US and globally. Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonRahway, NJ$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
Associate, Regulatory Affairs - Global Government Relations JPMorgan Chase Bank, N.A.Associate, Regulatory Affairs - Global Government RelationsNew York, NYFull timeAs the public policy environment globally is evolving rapidly due to technological change and a desire by policymakers to drive economic growth and international competitiveness, you will provide support to the CIB Regulatory Affairs team in responding to this dynamic environment and feed into the firm's advocacy, engagement, and strategic responses on key regulatory policy issues. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy Insmed IncSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyBridgewater, NJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA.