- Georgetown Univerisity (Washington, DC)
- …science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + FDA , ICH-GCP) Familiarity with regulatory ... regulatory compliance and oversight of a portfolio of clinical trials overseen by the Clinical Research...the Director of the CRO, the CRC will manage regulatory for complex clinical trials across multiple… more
- Evident Scientific (Needham, MA)
- Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident MIS) Job ID #: 2215 Company: Evident Posting Date: Nov 25, 2025 Are you looking for a ... day. **Let's inspire healthier lives, together.** This role bridges Clinical Affairs and US Regulatory ...Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards.… more
- 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
- Astellas Pharma (Northbrook, IL)
- …are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing...**External Engagement:** + Build and maintain strong relationships with FDA , PhRMA, ICH, other regulatory authorities and… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with ... personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments...oversight and governance of Regulatory Affairs department and involved in the day-to-day support of… 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