- 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, including 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …requirements with input from senior management. + Represent CMC/CP RA at program meetings and independently provide regulatory interpretation, position, ... be responsible for leading the development and execution of global regulatory strategies for biologic products and...perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and… 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
- 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
- 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
- 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)
- …execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating ... **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist)**...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director , HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and ... drug designation, diversity plans, etc.) * Working cross-functionally with medical affairs , clinical development, regulatory affairs , pharmacoepidemiology *… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …leaders, advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision ... The Senior Medical Director , Clinical Development will...key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This… 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Director , Digital Solutions is poised to be a...a wide range of partners, including IT, R&D, operations, regulatory affairs , and senior management. ... digital innovation strategy. This role will work with our global leadership team and program teams on the ground...best in an inclusive and dynamic environment. As the Director , Digital Solutions, a typical day may include: +… 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