Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteNew York, NYRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteNew York, NYRemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteNew York, NYRemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management 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.
NewAssociate Director, Data Quality & Integrity, Global R&D & PV QA Daiichi Sankyo, Inc.Associate Director, Data Quality & Integrity, Global R&D & PV QABasking Ridge, NJ$153,600–$230,400 / yearFull timeLeadership & Strategy Execution – Lead execution of key elements of the global Data Integrity strategy and ensure alignment across R&D, PV, and MA.Translate strategic objectives into multi‑year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus).Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk‑based prioritization and compliance posture. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.
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.
Director, 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/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteNew York, NYRemote$183,549–$275,324 / yearThe current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewManager, Global Vendor Quality, Global R&D & PV QA Daiichi Sankyo, Inc.Manager, Global Vendor Quality, Global R&D & PV QABasking Ridge, NJ$127,280–$190,920 / yearFull timeThis position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership. The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies.
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.
Associate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteNew York, NYRemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
Medical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentNew York, NY$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
Director 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.
Associate 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/ .
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.
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).
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).
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.
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 Liaison (CNS) AtriumMedical Science Liaison (CNS)Jersey City, NJ$140,000–$225,000 / yearThe position centers on establishing trusted scientific partnerships, delivering high-quality scientific exchange, and generating actionable insights to guide medical strategy and clinical readiness. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title.
Director, Cybersecurity Policy and Diplomacy Team (CPD) MicrosoftDirector, Cybersecurity Policy and Diplomacy Team (CPD)New York, NY$132,200–$258,000 / yearBachelors Degree in Public Policy, Public Administration, Political Science, Business Administration, Technology, Law, Liberal Arts, Engineering, or related field AND 6+ years work experience in government affairs, corporate affairs, public policy, government, or related area OR equivalent experience. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD $165,800 - $278,900 per year.
VP Professional Services, Study Experience Dassault SystèmesVP Professional Services, Study ExperienceIselin, NJ$216,000–$288,000 / yearCelebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. Experience: A minimum of 15 years of progressive experience in professional services, client services, or clinical operations within the life sciences industry (e.g., at a CRO, eClinical/SaaS vendor, Pharma, or Biotech).
Transactional 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.
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.
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.
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.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionNY$128,600–$210,000 / 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 guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
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.
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.
Regulatory Affairs Intern Phibro Animal Health CorpRegulatory Affairs InternTeaneck, NJPhibro 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.
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.
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.
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.
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.
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.
Senior Associate, US Regulatory Affairs BeOne Medicines AGSenior Associate, US Regulatory AffairsNY$93,600–$123,600 / yearThe Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Assoc Director, Regulatory Affairs - Advertising and Promotion Merck & Co IncAssoc Director, Regulatory Affairs - Advertising and PromotionRahway, NJ$129,000–$203,100 / yearRequired Skills: Clinical Trials, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Regulations, Negotiation, Pharmaceutical Industry, Promotional Review, Regulatory Compliance, Regulatory Labeling, Regulatory Strategies, Regulatory Submissions, Stakeholder Management, Strategic Thinking, US Regulatory Affairs. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
NewAssociate Director, Regulatory Affairs Project Management Insmed IncAssociate Director, Regulatory Affairs Project ManagementNJRemoteReporting to the Director, Regulatory Affairs Project management, you'll work with global submission teams to project, manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance's and Insmed Operating procedures. Have and be able to utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays.
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 Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Associate Director, Regulatory Affairs Advertising and Promotion Recordati SpAAssociate Director, Regulatory Affairs Advertising and PromotionBridgewater, NJ$137,600–$180,000 / yearRecordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. This role is responsible for supporting regulatory review and activities related to advertising / promotion of our marketed pharmaceutical products in 1 or 2 of the following therapeutic areas: oncology, endocrinology, hematology.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Director, DigitalizationFranklin Lakes, NJ$230,300–$368,500 / yearThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
NewSenior Manager / Associate Director, Regulatory Affairs CMC Shionogi Inc.Senior Manager / Associate Director, Regulatory Affairs CMCFlorham Park, New Jersey$140,000–$200,000 / yearServe as the primary CMC regulatory liaison with Health Authorities for designated assets, which involves guiding agency communications, creating briefing documents, handling information requests, and ensuring alignment with management on strategic or high‑risk issues before making commitments. Excellent verbal communication skills, with demonstrated ability to act as a regulatory CMC spokesperson and effectively communicate aligned regulatory CMC strategies and positions across working teams, cross‑functional forums, and senior leadership.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Associate Director, Regulatory Affairs, CMC BeOne Medicines AGAssociate Director, Regulatory Affairs, CMCNY$142,000–$192,000 / yearManage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity.
Associate Director, Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, Regulatory AffairsNYRemote$194,040–$228,250 / yearCreate and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting.