- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... filing in US and Europe. Position Summary: + Under the direction of regulatory affairs management, the incumbent independently prepares and directs global … more
- Novo Nordisk (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; ... Bachelor's degree or equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of 8 years of experience in … more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Associate Director , Solutions and Industry Partnerships -Vaccines **Location:** Remote **About the Job** As the Associate Director , ... designed for specific partnership channels + Work closely with HS Solutions, Public Affairs , HIT Solutions, Brand Marketing, and Market Access to ensure content both… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Merck (Upper Gwynedd, PA)
- **Job Description** **Title: Associate Principal Scientist/ Associate Director , Outcomes Research** **Role Summary** + Under the guidance of a senior leader, ... an Associate Principal Scientist/ Associate Director , has...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The… more
- Haleon (Warren, NJ)
- …supplements. In line with a risk-proportionate framework for product vigilance, the ** Associate Director , Consumer Safety Science** is accountable for developing ... experience of product safety related disciplines (eg, clinical development, medical affairs , regulatory ) preferred. + Professional qualification as healthcare… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research, Research, Informatics Services, Project Management and… more
- AbbVie (Branchburg, NJ)
- …Key Stakeholders: PST Lead, Search and Evaluation Team, Project Management, Regulatory Affairs , Discovery, Clinical Operations Additional Information Applicable ... or Development Safety Update Report) for early development assets *Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV… more
- Merck (Upper Gwynedd, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... create breakthrough science that radically changes the way we approach serious diseases. The Director will report to an Associate Vice President in the Oncology… more
- Merck (North Wales, PA)
- …partners including disease and alliance teams, research and development, medical affairs , regulatory affairs , market access, outcomes research, ... **Job Description** ** Director Global Marketing** Join our passionate marketing team and be a critical driver in bringing a new oncology asset to customers… more
- Merck (North Wales, PA)
- …a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Merck (Upper Gwynedd, PA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Clinical Director May… more
- Edwards Lifesciences (Trenton, NJ)
- …their span of influence/control The Sr Manager, Biostatistics Level is lateral to Associate Director , Biostatistics (" Associate Director Biostatistics") ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more