- BeOne Medicines (San Mateo, CA)
- **General Description:** This role is the head of Promotional Regulatory , and provides regulatory leadership, support, oversight, and strategic guidance on ... States with some activities globally to ensure compliance with applicable regulatory requirements and guidelines, and consistency with approved labeling. The role… more
- Actalent (Maryland Heights, MO)
- Job Title: Director of Regulatory Affairs Job Description The Director of Regulatory Affairs is tasked with overseeing Nuclear Medicine Regulatory Affairs ... or clinical studies. The Director will facilitate the success of key regulatory projects, manage dossiers, and coordinate with health authorities to obtain approvals… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening ... and cardiovascular conditions. **KEY RESPONSIBILITIES** The Associate Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory… more
- Stryker (Redmond, WA)
- Stryker is seeking an **Associate Manager, Regulatory Affairs,** to support **Emergency Care!** You will provide leadership, direction, and coordination for Stryker ... Medical Redmond's global regulatory strategies, registrations, and submissions - supporting both ongoing global market operations and high-impact product launches.… more
- Actalent (Boston, MA)
- Job Title: Director Regulatory CMC Job Description We are seeking a creative and agile regulatory professional eager to join a collaborative team as a ... Director/Sr. Director of Regulatory CMC based in Boston with a hybrid option....of current Good Manufacturing Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA,… more
- Stryker (Redmond, WA)
- We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **Redmond, Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market… more
- Bausch + Lomb (Madison, WI)
- …reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management ... (Rx/OTC, OTC Monograph, Nutritional, and Cosmetics). **Responsibilities:** + Interpret Regulatory Authority policies, regulations and guidances and correctly apply… more
- Abbott (Santa Clara, CA)
- …other regulatory requirements. + Complies with US Food and Drug Administration (FDA) regulations, international regulations and other regulatory ... Opportunity** We currently have several opportunities for the **Medical Device Regulatory Affairs Development (RAD) Program** to be located in Alameda, Pleasanton,… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- Regeneron is seeking a Manager, of Advertising and Promotion to join our Regulatory Affairs team!! **In this role, a typical day might include:** The Manager ... position within the Regulatory Affairs department requires the ability to apply clinical...in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for… more
- GE Aerospace (West Chester, OH)
- **Job Description Summary** The Regulatory Engagement Strategy Leader is responsible for managing the relationship framework with key regulatory bodies, ... freedom to operate, mitigate emerging risks, and influence the evolution of regulatory frameworks. This role works in robust partnership with GE Government… more