- Pfizer (New York, NY)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead,… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This ... application. We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of our day and improving the lives of patients for generations to come. As an Associate Director , Global Regulatory Affairs , you will act as the Regional ... Affairs and may serve as Regional Regulatory Lead or Global Regulatory ...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The ... role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply...Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday,… more
- Taiho Oncology (Princeton, NJ)
- …and coordinate regulatory activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or status ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Ascendis Pharma (Princeton, NJ)
- …their skills. The Regulatory Project Manager will be an integral part of Global Regulatory Affairs , providing project management leadership to key ... across the Ascendis pipeline. As a part of the Global Regulatory Affairs team, you...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …for new products. Preferred **Knowledge and skills** + Solid understanding of pharmaceutical regulatory affairs , global labeling regulatory requirements ... Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5 more}… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Novo Nordisk (Plainsboro, NJ)
- …Team, at the discretion of the Executive Director + Represent NNI Medical Affairs on Global Core Medical Team (CMT) + Collaborate with HEOR to provide ... Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Relationship/Scope: + This position reports to the Head of Global Medical Affairs . The Senior Medical Director will interact with internal colleagues in the ... Medical Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...boards + Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering… more
- J&J Family of Companies (Raritan, NJ)
- …Management, Project Integration Management, Quality Assurance (QA), Quantitative Research, Regulatory Affairs Management, Standard Operating Procedure (SOP), ... Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory , Strategic Partnerships, Human Resources. + External… more
