- 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)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as ... 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
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... post-approval work. Form 2252 for Annual Reports. + Provide support/ RA strategy needed to achieve timely approvals with the...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- Merck (Rahway, NJ)
- … Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) The Associate Director of Regulatory ... implement user requirements, workflows, and metadata standards. + Ensure compliance with global regulatory standards and internal SOPs for electronic submissions… 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
- 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
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC, the...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Merck (Rahway, NJ)
- **Job Description** The Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team. The ... Skills:** Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs … more
- Merck (Rahway, NJ)
- …years of experience in global patient advocacy and engagement activities + US/ global experience in regulatory affairs , medical and scientific affairs ... **Job Description** The Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Bristol Myers Squibb (Madison, NJ)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... executed in strict adherence to applicable regulations and BMS standards. The Executive Director leads a team dedicated to maintaining global compliance across… more
- Merck (Rahway, NJ)
- …best practices in those areas + US/ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical policy + ... , Oncology, Patient Advocacy, Patient Insights, Pharmaceutical Industry, Pharmaceutical Medical Affairs , Relationship Management, US Regulatory Affairs … 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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …programs from initial feasibility through full-scale commercialization. + Partner with global regulatory (clinical and CMC) for developing combination products ... with evolving requirements across FDA, EMA, PMDA, and other global authorities. + In concert with CMC RA...advanced degree. Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for… 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
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- J&J Family of Companies (New Brunswick, NJ)
- …of degree is required. Advanced degree in management, EHS technical field or regulatory affairs , preferred. **Other:** An advanced degree MS or MBA preferred. ... **Position Summary** Reporting to the Chief Sustainability Officer, the Senior Director , Enterprise Safety Solutions leads the strategic development and delivery of… 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
- 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
- Danaher Corporation (New York, NY)
- …Managers towards it; build and maintain strong relationships with R&D, Clinical & Regulatory Affairs , Marketing, Operations, and Quality + Own & improve Beckman ... with diagnostic tools that address the world's biggest health challenges. The Director , Product Portfolio Strategy and Enablement role is responsible for supporting… more