Manager Global Regulatory Affairs Job at Barrington James, San Francisco, CA

YnVLdkgrVWNYbmdQZWtRTnhxVE5mRXFHOEE9PQ==
  • Barrington James
  • San Francisco, CA

Job Description

About the Company:

I’m working with a dynamic, fast-growing Biotech company that is expanding its regulatory affairs team. With a strong presence across several major U.S. markets, the company is dedicated to advancing its projects while making a positive impact on consumer health.

Key Responsibilities:

  • Collaborate effectively with cross-functional teams and global/regional stakeholders to ensure alignment and clear communication.
  • Review reports, investigator brochures (IBs), and other safety-related documents to ensure accuracy, consistency, and completeness.
  • Oversee regulatory operations, including the preparation and submission of documentation

What We’re Looking For:

  • 5+ years experience regulatory affairs, or project management
  • Bachelor’s degree in biological or healthcare science.
  • Experience managing development, submission, and approval activities in different regions globally.
  • Experience with clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.

Job Tags

Similar Jobs

Community Volunteers in Medicine (CVIM)

Physician Assistant or Nurse Practitioner Job at Community Volunteers in Medicine (CVIM)

 ...Position Title: Physician Assistant or Nurse Practitioner Reports To: Medical Director FLSA Status : Exempt Job Type: Full-time...  ...solving and critical thinking skills. Experience in a community health clinic setting preferred. Spanish proficiency required.... 

Schulte Hospitality Group

Director of Food And Beverage Job at Schulte Hospitality Group

 ...service-oriented Director of Food & Beverage to join our Graduate...  ...Schulte Companies you'll be part of a team committed to an...  ...Plan + Company Match Paid Time Off Holiday Pay Pet Insurance...  ...Director of Sales on sales and marketing strategies Accountable for... 

Compass Group

STARBUCKS BARISTA (FULL AND PART TIME) Job at Compass Group

 ...We are hiring immediately for a full and part time STARBUCKS BARISTA position. Address : Ascension Alexian Brothers Medical Center - 800 Biesterfield Road, Elk Grove Village IL 60007 Note: online applications accepted only . Schedule : Full and part... 

BlackRock Resources LLC

Construction Scheduler Job at BlackRock Resources LLC

We are currently hiring a Construction Scheduler for our client in the Richmond, VA area. The position will pay an hourly rate, 1.5OT, per diem, MOB / DEBOB, health benefits, PTO, etc. Job Summary: In conjunction with Engineering, Procurement and Construction (...

FrostPoint Capital

Associate, Accounting & Finance Job at FrostPoint Capital

 ...Accounting & Finance West Palm Beach, Florida Full Time In person For immediate hire ABOUT THE COMPANY FrostPoint...  ...corporate and property level accounting, ensuring accuracy in financial reporting, assisting with cash management, and contributing to...