137 Results for

Director Of Regulatory Affairs Jobs in Princeton, NJ

Jobs

Warren, NJ10 days ago

This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. Oversees the day-to-day operations within the regulatory affairs function including oversight of submission coordination, submission publishing, advertising/promotional review, and process development/improvement initiatives.

New!

Lawrence Township, NJ2 days ago

$61.84–$65.59 Per Hour

This role involves key leadership responsibilities, and requires collaboration with internal teams and external partners, communication and presentations to business unit VP's, overseeing centralized operational activities that incentivize and enable field execution with a focus on process improvement. This is an important role within the Worldwide Commercialization Strategy & Operations Organization and key to Client's ambition to continue advancing the efficient and expeditious execution of field operations.

New!

Lawrence Township, NJ4 days ago

$77.58–$82.28 Per Hour

Responsibilities:Take on assigned projects to help with development and execution of functionally integrated and aligned medical communications plans; adjust communications plans in accordance with clinical trial results / milestones and changes in the healthcare landscape. In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication.

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Bernards, NJ2 days ago

Acting as QA point person for assigned programs, the Manager collaborates with GxP Quality representatives (Development QA, Audits & Compliance, Quality Management System (QMS) QA including Vendor Quality, Pharmacovigilance QA and provides guidance during the development and execution of Corrective and Preventive Actions (CAPAs), including tracking timely closure, effectiveness checks, and escalation of critical issues. Serve as a key liaison to support audits and inspections as applicable Cross-functional and Global Team Participation: Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DSBR) to proactively identify potential risks and opportunities for continuous improvement.

Lawrence Township, NJ11 days ago

$75.83–$80.43 Per Hour

Exceptional collaboration skills; this role requires daily partnership with a wide range of internal teams, IT partners, and external vendors; the ability to build strong working relationships across all levels is essential. This role requires someone who is equally comfortable driving meetings, managing complex PM documentation, supporting platform operations, and partnering with IT, commercial, and cross-functional matrix teams.

Bernards, NJ13 days ago

Lead 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.

Bernards, NJ10 days ago

This role will influence the external policy landscape so the value of Daiichi Sankyo's pipeline, portfolio, and business is protected and enhanced – allowing Daiichi Sankyo to continue bringing innovative medicines to patients who need them. Leverage subject matter expertise to assess potential policy implications to Daiichi Sankyo with internal stakeholders (e.g., Market Access, Regulatory Intelligence, etc.), develop DSI policy strategies and shape policy reform.

New!

Bernards, NJ2 days ago

Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.

Bernards, NJ7 days ago

Provide oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers. Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed.

Warren, NJ30+ days ago

$180,000–$220,000 Per Year
Full-time

Strong knowledge of current US and global regulations/gui Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands from a variety of R&D, Clinical, QA, Marketing, and Operations team Proven ability to communicate with executive management and external thought leaders. This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones.

Princeton, NJ30+ days ago

Full-time

The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive 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: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.

Philadelphia, PA8 days ago

Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.

New!

Trenton, NJ2 days ago

$55–$63 Per Hour

Design and implement comprehensive patient recruitment strategies at the protocol level, leveraging a broad mix of tactics, including partnerships with patient advocacy groups, recruitment vendors, digital solutions to enhance trial awareness, enrollment, and participant experience in alignment with overarching trial goals and timelines. This role will work cross-functionally with Clinical Operations, Global Development, Medical Affairs, Patient Advocacy, and external partners to deliver tailored recruitment solutions that address study-specific needs while supporting enterprise-wide objectives.

Princeton, NJ30+ days ago

$244,110–$295,806 Per Year

Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies—enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time. Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review—ensuring diverse expertise is integrated to drive precision medicine innovation.

Princeton, NJ25 days ago

Full-time

For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Warren, NJ30+ days ago

$190,000–$220,000 Per Year

This individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.

Princeton, NJ30+ days ago

$173,350–$210,100 Per Year

Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.

Summit, NJ8 days ago

$40–$47 Per Year
Temporary
Contractor
Full-time

Support the shaping and lead the execution of Neutrogena Makeup communication campaigns, partnering with multifunctional teams and leading creative and influencer agencies to deliver campaigns that drive mental availability for the brand and platform. The Brand Manager for Global Makeup is responsible for identifying and executing innovation, claims and communications required to drive global growth on the Makeup platform.

Trenton, NJ30+ days ago

$169,344–$264,600 Per Year

The responsibilities of the position include, but are not limited to, the following: + Demonstrate a high degree of knowledge about the political, economic, and social factors affecting public policy decision making; how engagement with government officials can lead to the enactment of new or the modification of existing regulations; implement policies and take other governmental actions that are favorable to Chemours’ business growth, corporate well-being, and the industry sectors in which the company operates. The successful candidate will join Chemours’ Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs.

Trenton, NJ30+ days ago

$165,000–$225,000 Per Year

12+ years of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or a related area of study. We are focused on the research and development of transplantable kidneys ( mirokidney® ), livers ( miroliver® ), and a bioengineered external liver assist device for acute liver failure ( miroliver_ELAP_® ), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

New!

Philadelphia, Pennsylvania2 days ago

$90,000–$100,000

University College supports Temple's mission by providing high quality education to its students that is accessible, affordable, diverse, and engaged with the broader community across its campuses at Ambler, Center City, Harrisburg, Main Campus, and online. The Director of Academic Affairs and Student Success provides leadership and operational oversight for academic programming and student success initiatives across the University College and its campuses, with a primary focus on the Bachelor of General Studies.

Madison, NJ30+ days ago

$207,490–$251,433 Per Year

This individual will be involved in integrated strategic planning within Global Medical Affairs under the direction of the US Medical Multiple Myeloma lead and Global Multiple Myeloma disease lead as well as in close partnership with the US Commercialization organization, Clinical Research and Development, HEOR, Market Access, Translational Development, and Regulatory, and will lead the US Medical asset strategy supporting the US and Global Multiple Myeloma Disease Leads. Provide high quality clinical input and review of congress abstracts, posters, presentation slides, manuscripts, educational materials, steering committee and advisory board meeting materials, medical information response documents, scientific educational grant requests, compassionate use requests, and patient advocacy grant requests among others.

Philadelphia, PA30+ days ago

Remote

$183,549–$275,324 Per Year

The current base salary range for this position is expected to be between $183,549 – $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. As a key cross-functional partner, the Medical Director collaborates closely with Commercial, Clinical Development, Regulatory, and Market Access teams, among others, to shape brand and portfolio strategy, integrating real-world evidence and external expert perspectives.

Florham Park, New Jersey30+ days ago

$280,000–$325,000 Per Year

Overview: The Senior Medical Director, Global Medical Affairs (Virology) provides global medical/scientific leadership for assigned assets, serving as a subject matter expert and strategic partner across cross-functional teams. Responsibilities: Provide end-to-end global scientific leadership and medical strategy for assigned assets, including accountability for asset-level Medical Affairs budgets, tracking, and compliance in alignment with Global Medical strategy.

Horsham, PA30+ days ago

Full-time

Provide Dermatology subject matter expertise and represent US medical affairs on internal stakeholder/ project teams across key functional areas within the US Immunology business including but not limited to sales and marketing, regulatory advertising and promotion (RAP), RWV&E, MSLs, Medical Communications and Scientific Exchange (MCSE), Training and Development, etc. Provide US medical affairs input and US stakeholder insights to New Business Development (NBD), Global Medical Affairs (GMAF), and Research & Development (R&D) to inform and shape pipeline clinical development programs, including but not limited to due diligence reviews, country and site selection, study designs, presentations, and publications.

Madison, NJ30+ days ago

$229,380–$278,000 Per Year

The MAPs Lead will provide strategic input, oversight, and coordination to ensure a streamlined and efficient approach to managed access and ensure equity, sustainability, scalability, and appropriate data capture across their respective disease areas. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.

Princeton, NJ30+ days ago

$166,350–$201,600 Per Year

Provides high quality scientific/clinical input and review of disease strategy/plans, abstracts, posters, presentation slides, manuscripts, educational materials including slides, webcasts, etc., IIT protocols, steering committee/ advisory board meeting objectives, materials, booth panels, Med info letters, CDPs, Commercial Brand plans, and Integrated Evidence Plans. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.

New!

East Windsor, New Jersey4 days ago

$190,000–$230,000 Per Year

Physical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). Job Overview : Lead the Dermatology US Medical Affairs team, as a valued strategic partner with Clinical, Commercial, and Marketing teams to bring innovative therapeutic solutions to improve the lives of patients and establish Acrotech as a leader in atopic dermatitis.

Monmouth Junction, New Jersey30+ days ago

Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.

Piscataway, NJ30+ days ago

$124,000–$174,000 Per Year

This high-impact role, sitting within the Global Consumer Affairs Team, reporting to the Senior Director of Global Consumer Affairs, is critical to the functional transformation of our worldwide Consumer Affairs organization, ensuring our technology strategy is flawlessly aligned and executed to provide a compliant, efficient, and best-in-class consumer experience across all divisions. Technical competency: Ability to translate business needs into technical requirements, manage SaaS vendors and IT partners, understand APIs/integrations at a working level and govern change processes (SLAs, root cause, CAPA, validation readiness).

Piscataway, NJ30+ days ago

$124,000–$174,000 Per Year

This high-impact role, sitting within the Global Consumer Affairs Team, reporting to the Senior Director of Global Consumer Affairs, is critical to the functional transformation of our worldwide Consumer Affairs organization, ensuring our technology strategy is flawlessly aligned and executed to provide a compliant, efficient, and best-in-class consumer experience across all divisions. + Technical competency: Ability to translate business needs into technical requirements, manage SaaS vendors and IT partners, understand APIs/integrations at a working level and govern change processes (SLAs, root cause, CAPA, validation readiness).

New!

Newark, NJ4 days ago

$38,100–$57,200 Per Year

If applicable, the successful applicant must prove they are: (1) a citizen or national of the USA; OR (2) a lawful permanent resident of the United States (Non-Conditional Permanent I-551 / Green Card / Permanent Resident Card holder); OR (3) a citizen, national, or permanent resident of a “Generally Authorized” destination on the attached list (https://corporate.pseg.com/-/media/PSEG/Corporate/Careers/Careers Assignments will include working alongside professionals in the following areas: + Sustainability Data Analytics: Gather and analyze enterprise sustainability data, determine qualitative and quantitative insights, conduct industry analysis and present findings to team members as needed to address the company’s strategy on sustainability, affordability and reliability.

New!

Florham Park, New Jersey6 days ago

$120,000–$150,000 Per Year

The individual operates with a high degree of autonomy for assigned responsibilities, applying regulatory knowledge and critical thinking to interpret data, ensure compliance, and guide regulatory activities with minimal direction. This role contributes to regulatory strategy execution and proactively identifies risks, drives solutions, and escalates as needed to support successful regulatory outcomes.

Madison, NJ30+ days ago

In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bridgewater, NJ30+ days ago

Full-time

Support agency interactions, including appropriate documentation of interaction, decisions and outcomes; contribute to the development of meeting requests, briefing documents and other supporting materialArchive management for related projects including submission archive and tracking submission/approval dates and Health Authorities correspondences. This position reports to the Functional Area Head, Global Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies, working closely with the cross functional teams to prepare, review and submit regulatory documents, manage documentation systems and maintain interactions with regulatory agencies.

Trenton, NJ30+ days ago

Our diverse analytics team of knowledge management experts, data scientists, analysts and data visualization specialists works on multiple projects simultaneously, ranging from piloting new capabilities, to developing cutting-edge approaches, to operationalizing complex solutions. Leading and in collaboration with our Innovation Lab team, this project lead will take accountability for all project phases including startup, execution and change management, ensuring the right solution is developed for the right stakeholder at the right time.

Princeton, NJ30+ days ago

$86,700–$102,000 Per Year
Full-time

The Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.

Philadelphia, PA30+ days ago

$62,000–$70,119 Per Year

Qualifications: The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The Regulatory Affairs Specialist-CC is expected to facilitate the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials.

Trenton, NJ30+ days ago

The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across WWPS.

Princeton, NJ30+ days ago

$226,750–$274,763 Per Year

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products: Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.

Princeton, NJ30+ days ago

$425,000–$515,000 Per Year

As thesenior-most medical leader for ICV, the SVP will sit on the Worldwide Medical Leadership Team, partner deeply with R&D, Commercial, Market Access, and Policy leaders, and serve as the global medical face of BMS to regulators, academia, professional societies, and patient communities. This is a mission-defining enterprise role for a highly credible leader who operates seamlessly across early development through lifecycle maturity, shaping evidence, influencing global practice, and ensuring BMS delivers practice-changing, equitable impact for patients worldwide.

Philadelphia, PA30+ days ago

$105,500–$130,000 Per Year

The Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania’s Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will assist the Director with facilitating and tracking the flow of new research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process will track, analyze and report to senior leadership department-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions.

Madison, NJ30+ days ago

$265,460–$321,700 Per Year

The Executive Director, Medical Affairs Strategy and Operations Head is responsible for leading a team of S&O colleagues and project managers who are charged with partnering with colleagues in WW Medical Affairs or in other functions to lead or support the business operations and execution of the oncology portfolio. There is a critical need in this complex ecosystem of therapeutic assets and disease areas to bring rigorous strategy and execution to portfolio optimization, evidence generation across the portfolio and to ensure effective, repeatable launches that will benefit patients.

Princeton, NJ30+ days ago

$284,730–$334,980 Per Year

Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Philadelphia, PA30+ days ago

$66,000–$80,000 Per Year

The primary responsibilities of the position include initiating, contributing to, and managing the development of multiple gene editing projects; assisting the research team in generating study reports that cover project development, research design, data collection, and quantitative analyses; assisting the research team in preparing manuscripts, publications, and grant applications; training and supervising staff, as well as interfacing with existing postdoctoral fellows and students in the laboratory; and overseeing recordkeeping for laboratory projects to facilitate the preparation of regulatory submissions. + Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility.

Philadelphia, Pennsylvania17 days ago

THE NURSING DEPARTMENT: The Department of Nursing at Barnett College of Public Health at Temple University aims to be a leading force in community-engaged, collaborative efforts to achieve health equity and a quality of life for all, preparing a diverse nursing workforce who excel in leadership, practice, research and scholarship. The DNAP Program Director will be expected to teach courses within the DNAP program, and direct the organizational administration of the post-BSN to DNAP program by providing leadership and oversight for all aspects of the program including governance, didactic and clinical curriculum, recruitment, and evaluation.

New Brunswick, NJ30+ days ago

The External Manufacturing Quality Organization is seeking to recruit a Manager, Regulatory Affairs who will report directly to the Associate Director, Regulatory Affairs and will be responsible for all regulatory support activities within External Manufacturing. Reports, CoA's, Analytical raw data) to support regulatory requests for post approval variations, renewals, and.

Philadelphia, PA30+ days ago

Remote

$229,562–$344,342 Per Year

The role oversees a high-impact team and partners cross-functionally and externally to drive an integrated publications and scientific communications strategy, translating complex data into compelling evidence that supports clinical adoption, informs healthcare decision-making, and differentiates the company’s portfolio globally. Agios Pharmaceuticals is searching for a dynamic Senior Director, Global Scientific Communications and Publications expert to join our Global Medical Affairs team and lead a high-functioning communications/publications/congress team.

Philadelphia, PA30+ days ago

Education or Equivalent Experience: Bachelor of Science -Education Specialization: Biological and Chemical Sciences or related healthcare field Equivalent Experience and 5+ years Clinical lab experience and must meet requirements as a general supervisor under CLIA-88 •And Additional education and/or training in Management or Lab Management •And 5+ years Experience managing high volume clinical labs while meeting superior customer satisfaction expectations. Summary: The incumbent's primary responsibility is to manage the daily technical and administrative functions of their individual laboratory section(s); ensure compliance with institutional and laboratory policies and procedures; evaluate and recommend technical methods based on clinical and financial parameters; ensure that written and approved technical procedures and documentation are maintained for each determination performed; manage personnel, and all fiscal affairs.

Princeton, NJ30+ days ago

$229,380–$277,956 Per Year

The role supports the development and implementation of the Global/US Pumitamig Medical Plan, leads or collaborates within Alliance Medical and cross-functional forums which includes the development of Integrated Evidence Plans (IEPs), scientific narratives, publication plans, congress strategies, field medical trainings, and external engagements. In collaboration with Global Medical Evidence Generation Team and within the Alliance partnership, develops and executes the integrated evidence generation plan (IEP), including Medical Affairs Pumitamig breast cancer and other rare tumors trials, and evaluation of Pumitamig breast cancer and other rare tumors investigator-initiated or collaborative trials.

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Director Of Regulatory Affairs Jobs in Princeton, NJ

Jobs

Director, Regulatory Affairs StrategyAquestive Therapeutics

Regulatory & Medical Affairs - Senior Manager, Field Administration, CommercialECLARO

Medical and Regulatory Affairs - Cell Therapy Medical Communication SpecialistECLARO

Manager, Medical Affairs Quality, RD PV QADaiichi Sankyo, Inc.

Regulatory & Medical Affairs - Project ManagerECLARO

Senior Director, Clinical Safety ScientistDaiichi Sankyo, Inc.

Associate Director, Public PolicyDaiichi Sankyo, Inc.

Senior Director, Global Clinical LeadDaiichi Sankyo, Inc.

Associate Director, PV Strategic Partner ManagementDaiichi Sankyo, Inc.

Director, Regulatory Affairs StrategyMonosol Rx, LLC

Director/Sr. Director/Executive Director, Clinical Regulatory AffairsSystimmune

Director, Regulatory Affairs, Ex-USLarimar Therapeutics

Patient Recruitment SpecialistLancesoft Inc

Director, Early Precision Medicine Regulatory AffairsBristol Myers Squibb

Associate Director, Global Regulatory Affairs, Advertising & PromotionGenmab

Director, Regulatory Affairs StrategyJudge Group

Associate Director, Commercial Regulatory Affairs- Advertising and PromotionBristol Myers Squibb

Global Brand ManagerYANTRAN LLC

Regulatory Affairs Director (US)Chemours

Associate Director, Regulatory AffairsUnited Therapeutics

Director of Academic Affairs and Student SuccessTemple University

Director, US Medical Affairs, Multiple MyelomaBristol Myers Squibb

Medical Director, Global Medical Affairs - RemoteAgios Pharmaceuticals

Senior Medical Director, Global Medical Affairs (Virology)Shionogi Inc.

Medical Director, Dermatology - US Medical AffairsJohnson and Johnson

Senior Director, Managed Access Programs, Medical Evidence Generation (Worldwide Medical Affairs)Bristol Myers Squibb

Associate Director, US Medical Affairs, Cell Therapy Autoimmune, LCM/PAN-IndicationBristol Myers Squibb

Director, Medical Affairs - DermatologyAcrotech Biopharma Inc

Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)Essenlix

Consumer Affairs Global Systems & Ops Manager (Piscataway, NJ, US)Colgate-Palmolive Company

Consumer Affairs Global Systems & Ops ManagerColgate-Palmolive

Summer 2026 Staff Intern - Corporate Citizenship - Federal Affairs & SustainabilityPSEG

Manager, Regulatory Affairs - GDPShionogi Inc.

Regulatory and Medical affairs - Sr. Manager, US MedicalTechDigital Corporation

ManagerSr. Manager - Regulatory AffairsGan & Lee Pharmaceuticals

Regulatory & Medical Affairs - Project ManagerTechDigital Corporation

Specialist, Regulatory Affairs Operations PublishingTaiho Oncology

Regulatory Affairs Specialist-CCUniversity of Pennsylvania

C08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALISTTechDigital Corporation

Senior Director, Global Regulatory Lead NeuroscienceBristol Myers Squibb

Senior Vice President, Worldwide Head of Medical Affairs, Immunology & CardiovascularBristol Myers Squibb

Associate Director, RegulatoryUniversity of Pennsylvania

Executive Director, WW Medical Oncology, Head of Strategy and OperationsBristol Myers Squibb

Executive Director, Head of Pharmacovigilance - Safety ScienceBristol Myers Squibb

Associate Director of Gene EditingUniversity of Pennsylvania

Doctor of Nurse Anesthesia Practice (DNAP) Program Director and Instructional FacultyTemple University

Quality - Regulatory Operations ManagerTechDigital Corporation

Senior Director, Global Scientific Communications and Publications - RemoteAgios Pharmaceuticals

Technical Lab Manager-Hematology and Coagulation at the Hospital of the University of PennsylvaniaPenn Medicine

Senior Director, Global Medical Oncology, Pumitamig Breast Cancer and Other Rare TumorsBristol Myers Squibb

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