- 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
- 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 ... + Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience authoring and/or implementing processes. +… 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
- IQVIA (Parsippany, NJ)
- …regulatory document types; * May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications; * May be assigned ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… more
- Merck (West Point, PA)
- …Us:** The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed 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
- AbbVie (Florham Park, NJ)
- …standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in the ... level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - ... Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology ... goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing… 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
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs + Contribute to develop Quality Management… 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
- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …and new people to make a difference with. **The opportunity** The Senior Director , Associate General Counsel, Market Access and Pricing role reports directly ... Associate General Counsel, Market Access & Pricing Date:...US, as well as providing legal support to Government Affairs and Payor Marketing. This role partners principally with… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …people to make a difference with. **The opportunity** The Sr. Director , Associate General Counsel, Transactions & Corporate Affairs role reports directly to ... Associate General Counsel, Transactions Date: Jan 6, 2025...functions, including R&D, intellectual property, supply chain, finance, and regulatory affairs . This role will also help… 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