- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …best self. Become a **maker of possible** with us. **Job Overview** Working closely with the Director of Regulatory Affairs , the Regulatory Affairs ... the regulatory landscape effectively. **Responsibilities** + Proactively monitor global regulatory developments to identify potential impacts on product… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Partnerships: Actively participate in operational optimization activities by collaborating with Regulatory Affairs , Global Patient Safety, Development ... Global Patient Safety Organization is looking for a Director , PV Enablement to join the team!! **In this...liaison between the PV department and other functions, including Regulatory Affairs , Development Quality, and Regeneron. +… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Clinical Subteams. + Partner with Medical Directors, Clinical Scientists, Regulatory Affairs , Preclinical Scientists, Statistical Programming, Data Management, ... is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. This position requires an individual with a strong… more
- AbbVie (Florham Park, NJ)
- …scientific and medical expertise to cross-functional teams, including research and development, regulatory affairs , market access, and commercial teams. + Ensure ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Scientific/Medical Director , Pipeline Medical Strategy - Psychiatry is a highly...compliance with regulatory and ethical standards in all medical … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Clinical sub-teams. + Interact with Medical Directors, Clinical Scientists, Regulatory Affairs , Preclinical scientists, Statistical Programming, Data Management, ... is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development. **In this role, a typical day might include:** The… 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
- Mondelez International (East Hanover, NJ)
- …Quality-related matters for the US Business Unit; (b) partner with Scientific & Regulatory Affairs Committee, the Brand Teams, and the Nutrition Strategy, ... team to keep them abreast of significant decisions, legislation, and governmental regulatory rulings that may affect the Company's regulatory , food law,… 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
- Organon & Co. (Jersey City, NJ)
- …of industry experience in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Tanabe Pharma Group, including… more
- City of New York (New York, NY)
- …teams involved in critical areas like drug-resistant TB case management and regulatory affairs . This position requires a highly organized, detail-oriented, and ... take clear and concise meeting minutes. - Assist the Regulatory Affairs Coordinator: Support the preparation and...outbreak to the COVID-19 pandemic, we serve as a global leader in public health innovation and expertise. Come… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships with opinion leaders ... Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC, Biostatistics, GCO, in the execution of… more
- Capgemini (New York, NY)
- …& Experience** **Skills & Experience (Required)** + **12+ years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10+ successful ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant At Capgemini...(no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …risk assessments, method development, and validation activities, supporting compliance with global regulatory requirements and internal quality standards. The ... requires strong collaboration with cross-functional teams, including Platform Product R&D, Regulatory Affairs , and Manufacturing, to deliver safe, effective, and… more