- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director … more
- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory ... Global Regulatory Strategy is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for… more
- Bristol Myers Squibb (Madison, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead ... MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements**… more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Advertising and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... partner across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- New York State Energy Research and Development Aut (New York, NY)
- …passion to work in a fast-paced environment on the cutting edge of energy policy. The Director , Legal and Regulatory Affairs will report directly to the NY ... York is leading the nation in the fight on global climate change and the transition to a clean...Bank's Managing Director , Head of Legal and Regulatory Affairs and be charged with anticipating… more
- New York State Energy Research and Development Aut (New York, NY)
- …senior attorney (the "MD-L&R") to join its management team, lead its Legal & Regulatory Affairs ("LRA") team and provide legal advice and strategic counsel with ... York is leading the nation in the fight on global climate change and the transition to a clean...being directly responsible for a variety of legal and regulatory affairs activities and deliverables at the… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs (BRANDED PRODUCTS) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Overview The ... Contractor - Senior Manager, Regulatory Affairs - Quality of Life (QOL),...meetings related to QOL initiatives. + Support coordination with global regulatory counterparts to ensure alignment of… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease...may develop and implement policies and procedures within the RA department and ensures direct reports follow requirements. Ensures… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** + The Director ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global ... to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your day** The Director ,… more
- Unilever (Englewood Cliffs, NJ)
- …local/national regulatory requirements and Unilever standards. Work with Legal and Regulatory Affairs to implement new legal requirements. + Manage change to ... of the Job The Ice Cream North America SHE Director has overall responsibility for managing Personal and Process...standards, policies, and practices to ensure SHE compliance with regulatory and Unilever expectations. + Support global … more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre-clinical and translational work… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and activities + Collaborate closely with cross-functional teams, including R&D, regulatory affairs , marketing, sales, and finance, to drive alignment ... Senior Director Biosimilar Strategy Date: Sep 23, 2024 Location:...the biosimilar landscape. Analyze market dynamics, customer needs, and regulatory requirements to inform strategic decision-making + Stay updated… more
