- 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
- 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
- Pentax Medical (Montvale, NJ)
- …manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Position Opening: Director , Global ... Time Off and Holiday policy. Want More INFO? The Director , Global Compliance will be a...the PENTAX Medical organization (legal, HR, operations, internal audit, QA/ RA , sales and marketing) with primary focus on the… 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
- 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
- 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
- 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 ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… 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
- 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)
- …to operational improvements across areas such as case management for drug-resistant TB, regulatory affairs , and the evaluation of newly arrived immigrants and ... from surveillance systems and electronic medical records. Assist the Regulatory Affairs Unit in drafting Commissioner's Orders...outbreak to the COVID-19 pandemic, we serve as a global leader in public health innovation and expertise. Come… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …colleagues and work closely with key members of internal departments including, Legal, Regulatory Affairs , Marketing, Global Health Economics, Value and ... This review is done in collaboration with Legal and Regulatory members (PARC, Promotional Advertising Review Committee) to ensure...etc.), and coordinates review with USMA therapeutic area Medical Director , Global Medical Director , USMA… more
- Reckitt (Parsippany, NJ)
- …all brands in close alignment with key business partners such as Quality, Regulatory Affairs , Health & Safety, Legal, Corporate Security Leadership, etc. 3. ... Reckitt is prepared for transboundary and high-impact disruptions. You will report to the Global Crisis Management Director and will work closely with global… more