- Gilead Sciences, Inc. (Foster City, CA)
- …responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance is met for assigned product (s) and territories. + Prepare ... and territories. + Responsible for ensuring preparation of the Product Company Core Data Sheets (CCDS), regulatory ...information is updated and maintained in accordance with the product license . Acts as project team representative… more
- Hologic (Louisville, CO)
- …Surgical division is seeking a Regulatory Affairs Specialist to drive global product commercialization, support New Product Development (NPD), and ensure ... and Marketing-participating in design reviews and developing regulatory strategies for product approvals. + Actively support NPD projects and manage the … more
- Haleon (Warren, NJ)
- … strategy to deliver timely approvals for US submissions and OTC Monograph product launches. + Develop and implement regulatory strategies and documents for ... US-specific activities and ways of working, processes as mentor or coach; provides support , as needed, for meetings/teleconferences with US regulatory agency +… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and ... product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate… more
- Abbott (Alameda, CA)
- …maintaining annual licenses, registrations, listings and patent information. + Provide regulatory support for internal and external audits **Required ... develop and manage regulatory professionals. + Provide regulatory input to product lifecycle planning. Monitor... management. Provide strategic input and technical guidance on regulatory requirements to development teams to support … more
- Globus Medical, Inc. (Audubon, PA)
- …of clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with ... plans, procedures and regulatory decisions for existing products + Reviews regulatory requirements from other departments for product designs or changes to… more
- Teleflex (Morrisville, NC)
- …workplace culture and positively influence those around them. **Principal Responsibilities** * Provide Regulatory support and serve as the RA Lead in the team ... that will shift this dynamic, reduce costs, and enhance product margins. Under Strategic Regulatory Affairs Team...regulatory impacts are captured for each project. * Support the Program Lead in developing RA timelines in… more
- Organon & Co. (Jersey City, NJ)
- …+ Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for development programs and marketed products + Independently ... as well as post-approval products with limited clinical development + Regulatory product and compliance management (coordinates the preparation, submission… more
- Gilead Sciences, Inc. (Foster City, CA)
- …packaging and associated information is updated and maintained in accordance with the product license . + Provides strategic regulatory advice as appropriate. ... regulatory documents including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original… more
- GE Vernova (Wilmington, NC)
- …procedures and support business needs including in finance, commercial, project, product and human resources + Support the development of Licensing Proposals ... **Job Description Summary** The US Licensing Manager, Regulatory Affairs, will lead a licensing team and...power plant licensing, operating plant reload licensing, customer plant support on GE Hitachi (GEH) / Global Nuclear Fuels… more