- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command… 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
- 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 (Princeton, 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
- 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
- Capgemini (New York, NY)
- …and lessons learned. **Skills & Experience (Required)** + **12 years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10 successful ... (no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND →… 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
- 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
- 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
- Merck (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... skills and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues + Demonstration of… more
- Ascendis Pharma (Princeton, NJ)
- …Collaboration + Partner with cross-functional teams including Clinical Development, Regulatory Affairs , and Commercial to align training initiatives ... Facilitation and Trainer Certification + Lead live and virtual training sessions for global Medical Affairs teams, ensuring high levels of engagement and… more
- J&J Family of Companies (Raritan, NJ)
- …Inclusive Leadership, Innovation, Leadership, Leverages Information, Motivating People, Regulatory Affairs Management, Research Ethics, Systems Development, ... as a single submission. **We are searching for the best talent for a Director Data Acquisition to be located in Spring House, PA; Titusville, NJ; or Raritan,… more
- Danaher Corporation (New York, NY)
- …collaborating with cross-functional teams including Product Management, Legal, IP, Finance, R&D, Regulatory Affairs , Clinical Affairs , Sales & Marketing, ... of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen,...to execute with supporting organizations (sales, commercial marketing, medical affairs , R&D, manufacturing, regulatory , quality, etc.) on… more