- Novo Nordisk (Lexington, MA)
- …documents to regulatory agencies. Relationships Report to a Director of Regulatory Affairs . Develop and maintain positive rapport and working relationships ... partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges...with other personnel in Regulatory Affairs and other local and headquarter… more
- Novo Nordisk (Plainsboro, NJ)
- …Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain… more
- AbbVie (Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Manager , Regulatory Affairs In Vitro Diagnostics and Companion ... implements, and documents policies and procedures within the regulatory affairs department under supervision of manager . Participates in initiatives internal… more
- CSL Behring (King Of Prussia, PA)
- …market biotherapies used to treat serious and often rare conditions. Could you be our next Manager of Global Regulatory Affairs ? The job is located in the ... a hybrid position. You will report to the Regional Regulatory Therapeutic Area Director Lead. **Responsibilities:** +...Lead. **Responsibilities:** + You will plan, direct, and monitor regulatory affairs activities so we have the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a direct impact. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Vendor Governance is a function within the RA Business ... and overall success of the vendor partnerships utilized by Regulatory Affairs . Gilead Sciences is seeking an...to resolve + Maintains knowledge of company disease and therapeutic areas + Has an appropriate level of IT… more
- Merck (Rahway, NJ)
- …is in regulatory affairs . **Required Experience and Skills:** + Regulatory experience preferred for therapeutic area experience in vaccine or infectious ... **Job Description** The Director, Regulatory Affairs Liaison, is responsible for...their assigned projects in the Vaccines and Infectious Disease therapeutic area. The selected individual will function with a… more
- Bausch Health (Bothell, WA)
- …aesthetic care options to consumers and physicians alike. Reporting to the Sr Dir, Global Regulatory Affairs , the Sr Manager , Regulatory Affairs ... technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been...globally distributed products. This role is not a regional regulatory but global regulatory position which under… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in our ... commercialization. + Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the… more
- Bausch Health (Bothell, WA)
- …proven and effective aesthetic care options to consumers and physicians alike. The Manager , Regulatory Affairs provides direct support to Solta operations ... technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been...Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience… more
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Regulatory Affairs , Strategic Global Labeling - Combination Products and ... a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care...trends and best practices in combination product and device regulatory affairs , review and comment on changing… more
- Sanofi Group (Cambridge, MA)
- …experience in the following areas: + Experience within pharmaceutical or medical device Regulatory Affairs . + Successful track record with ideally 1-3 years ... **Position Overview:** With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …reflect Boehringer Ingelheim's high regard for our employees. The Executive Director, Regulatory Affairs Excellence is responsible to establish and promote a ... culture of excellence across all areas of the regulatory affairs department. This leadership role focuses...a direct impact on the efficient translation of HP, Therapeutic Areas, and asset strategies into competitive regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Specialist I - Regulatory Affairs will support the maintenance of EU MDR technical documentation ... and conduct other elements of sustaining Regulatory Affairs including maintaining "state of the art". In addition, this position will support the regulatory … more
- AbbVie (Chicago, IL)
- …or Industry-related experience. + Preferred Experience: 5 years in pharmaceutical regulatory affairs . + Demonstrates effective communication skills in written ... has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director),… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the...various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Purpose: The Director Regulatory Affairs Global Regulatory Lead in Global ... strategies to secure and maintain market approval for product(s) in assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Project… more
- BeiGene (Emeryville, CA)
- …monitor the medical literature and conference abstracts for new reports in the therapeutic area for inclusion in Medical Affairs resources + Incorporate insights ... to BeiGene SOPs, work instructions, and quality standards + Apply legal, regulatory , and compliance requirements to all Medical Affairs activities **Supervisory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support ... clinical practice, training, and education. + Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs , clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direct impact. Join Gilead and help create possible, together. **Job Description** ** Manager , Global Medical Affairs , Oncology/GI/Pipeline** Gilead Sciences is a ... We have an exciting opportunity within our Global Medical Affairs team for a Manager , Global Medical...preferred + Industry experience with knowledge of all applicable regulatory and legal requirements for Medical Affairs … more
- Teleflex (Morrisville, NC)
- Clinical Affairs Manager **Date:** Apr 7, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 50% **Requisition ID** :9734 ... that make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides clinical expertise, insight and support to clinical… more