- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
