The Senior Regulatory Affairs Specialist creates, evaluates and completes International regulatory projects consistent with the company goals. The successful candidate is responsible for assembling regulatory submissions and international dossiers to...
The Senior Regulatory Affairs Specialist will independently plan, coordinate, conduct, and report on company Regulatory Affairs Programs. This includes activities such as preparation of clearance/approval/registration/licensure documentation for...
Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal focus. Our mission is to serve patients through the discovery, development and commercialization of minimally-systemic therapeutics that target...
Biotest Pharmaceuticals Corporation
Supervises and participates in the planning, preparing and interpreting documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well...
Five Prime Therapeutics, Inc.
South San Francisco,
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company focused on discovering and developing transformative protein-based medicines for patients with serious unmet medical needs. The company has an emerging portfolio of...
The Director/Senior Director, Commercial Regulatory Affairs (level dependent upon experience) will guide, direct and coordinate the strategic planning and execution of the regulatory solutions to diverse promotional scenarios in support of the...
AstraZeneca Pharmaceuticals LP
There are 2 roles open for the RAD positions--each representing a different therapeutic area: Oncology and RIA - (Respiratory, Inflammation & Autoimmune) The RAD Oncology position can be located in Gaithersburg, MD or Redwood City, CA. The RAD...
Miltenyi Biotec, Inc.
Do you possess an exceptional attention to detail and the ability to manage multiple projects at a time? Are you passionate about regulatory affairs? If so, come and join us as a…
Regulatory Affairs Manager
As a key member...
GQR GLobal Markets
North Jersey or San Diego,
GQR Life Sciences is currently recruiting an experienced Director, Global Regulatory Affairs CMC for a rapidly growing biotech based in San Diego and New Jersey. The company is seeking motivated team players with small molecule and post-approval...
The Manager, US Regulatory Affairs - Global Development Projects (GDP) will assist the department with: completing regulatory correspondence and submissions; assembling IND and NDA submissions; performing Quality Control reviews of regulatory...