- Boehringer Ingelheim (Ridgefield, CT)
- …drug development experience/knowledge with a minimum of ten (10) years' experience in Regulatory Affairs , FDA , or equivalent experience in the regulated ... drug development experience/knowledge with a minimum of eight (8) years of experience in Regulatory Affairs , FDA , or equivalent experience in the regulated… more
- Boehringer Ingelheim (Ridgefield, CT)
- … strategy expertise/knowledge in one or more therapeutic areas. Interact effectively within Regulatory Affairs and across functions, as a US regulatory ... common goals for assigned projects, with supervision. With supervision, the Product Group Regulatory Affairs Fellow will: + Regulatory Professionalism: + As… more
- Sumitomo Pharma (Little Rock, AR)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... individual will be responsible for leading development of all non- clinical and clinical regulatory strategies...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the...to ensure that the product development process - including clinical studies and strategy - addresses all regulatory… more
- Kelly Services (Norcross, GA)
- …BLA submissions** . + Experience supporting multicenter clinical trials and FDA BIMO audits. + Strong relationships with regulatory agencies and consultants. ... a direct hire opportunity in the Norcross, GA area for a Director, Regulatory Affairs (Transfusion).** **Director, Regulatory Affairs (Transfusion)**… more
- PCI Pharma Services (Rockford, IL)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... matters of government and regulations, with respect to the FDA , DEA, MHRA, EEU, State of Illinois, and other...and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing… more
- Philips (Plymouth, MN)
- …+ You've acquired 10+ years of experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, ... The Director, Regulatory Affairs will lead the Philips...cross-functional partnerships with key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all… more
- Medtronic (North Haven, CT)
- …for this opening will close on - 30 Dec 2025 **Position Description:** Sr. Regulatory Affairs Specialist for Covidien, LP (a Medtronic company) located in North ... design/manufacturing change notifications, QMS audits, and Manufacturing site registrations. Provide Regulatory Affairs support for maintenance of Core Suture… more
- Kelly Services (Norcross, GA)
- …to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / ... the Role** We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market ...in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA , Health Canada,… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs , is responsible for preparing, filing and gaining approval ... labeling in terms of indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality, Management and other areas of the organization… more
- Kelly Services (South San Francisco, CA)
- …for CMC and non- clinical information + Mentor and develop a high-performing regulatory affairs team and foster a collaborative work environment + Act as ... Science & Clinical ** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late clinical -stage,… more
- Boehringer Ingelheim (Ridgefield, CT)
- … and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will ... **Description** The Regulatory Affairs Fellow - Advertising and...compliance with the Food Drug and Cosmetic Act (FDCA), FDA Guidance, and the current Regulatory landscape.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- J&J Family of Companies (Irvine, CA)
- …containing software _preferred_ . + Proven expertise in all aspects of Regulatory Affairs , Submission Preparation, FDA Device Law/Regulations, Worldwide ... and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory … more
- Boehringer Ingelheim (Ridgefield, CT)
- … and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will ... opportunity to complete rotations in areas within and beyond Regulatory Affairs . The Fellow will be exposed...process initiatives. + Own the review and refinement of regulatory FDA guidance and recommendations by developing… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract-to-hire position with one of our clients, a leading ... Remote (US Pacific Time **)** **Pay:** $55-80 per hour **Position title:** Regulatory Affairs Principal, NGS IVD **Position type:** Contract-to-hire **Overview**… more
- Bayer (Washington, DC)
- …minds to make a real difference, there's only one choice.** **Director, Regulatory Affairs , Molecular Imaging** Join Bayer's Radiology Business unit, where ... cutting-edge technology and strategic regulatory leadership. As the Director of Regulatory Affairs , you will represent our medical device regulatory … more
- BeOne Medicines (San Mateo, CA)
- …advanced degree preferred + Preferred candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior experience with both ... **General Description:** The Director, Regulatory Affairs will be responsible for...are met. Externally, the individual will interface with outside regulatory agencies and more specifically, the FDA ,… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is ... us. **Position Summary:** We are seeking a Sr. International Regulatory Affairs Specialist to join our ...+ Evaluate design, manufacturing, and process changes for global regulatory impact. + Review analytical and clinical … more
- Abbott (Alameda, CA)
- …working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site ... monitor their glucose levels with our new sensing technology. This **Principal Regulatory Affairs Specialist** position is responsible for leading strategic… more