- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. + Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or more years with direct regulatory affairs experience + Experience in … more
- AbbVie (Florham Park, NJ)
- …Follow @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
- J&J Family of Companies (Raritan, NJ)
- …impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Global Medical Affairs Operations Excellence will report directly ... Strategy and Execution - Oncology and supporting the Vice President of Global Medical Affairs - Oncology. The Senior Director will play a critical role… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs...Global Regulatory Project Teams; and represents Regulatory Affairs on various other process and… 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 ... strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory ...+ Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience:… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- New York State Energy Research and Development Aut (New York, NY)
- … 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
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs ...Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory ... days onsite) 12-month contract (renewable) Overview The Contractor - Senior Manager, Regulatory Affairs -...QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory … more
- Vantage Specialty Chemicals (Fairfield, NJ)
- … compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs . The person will be responsible ... it here. For more information visit: www.vantagegrp.com or LinkedIn/vantage **POSITION SUMMARY** Regulatory Affairs Senior Manager is responsible for leading… more
- Bristol Myers Squibb (Madison, NJ)
- …and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs , Managed Care, Pharmacovigilance, Market Access, Statistics, ... Medical + Clinical Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC- Regulatory + Manufacturing and Quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- … global regulatory filings. **How you'll spend your day** The Senior Director : + Will foster relationships with opinion leaders in assigned ... Senior Director Clinical Development - Respiratory...Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Biosimilar Strategy Date: Sep 23, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56832 **Who ... on strategic decisions and workload associated with building the department. This Senior Director must have strong relationships and communication skills as… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Associate General Counsel, Transactions Date: Sep 12, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... their interdependent functions, including R&D, intellectual property, supply chain, finance, and regulatory affairs . This role will also help oversee internal… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate corporate personnel is informed of the progress of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Merck (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. **Specifically, The Senior Director May Be Responsible For** + Evaluating pre-clinical ... talented and dedicated colleagues while developing and expanding your career. The Senior Director ( Senior Principal Scientist) has primary responsibility… more
- Pfizer (New York, NY)
- …leaders and projects team members, including research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... plan, IND, AR, CSR, investigator brochure, statistical analysis plan and regulatory documents. + Foster a transparent environment that encourages strong partnerships… more