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

NkpVdFJXckhENVVtdS83WTNxcjc0aTJTcVE9PQ==
  • 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

BIP

Senior Java Developer, Capital Markets Financial Crimes (Quantexa Platform) Job at BIP

Company Overview: Business Integration Partners (BIP) is Europes fastest growing digital consulting company and are on track to reach the Top 20 by 2030, with an expanding global footprint in the US (New York, Charlotte, Chicago, and Houston). Operating at the intersection...

ColumbiaCare Services

Mental Health Associate - 5177 Job at ColumbiaCare Services

APPLY TODAY AND MAKE A DIFFERENCE IN THE MENTAL HEALTH FIELD! What We Offer Enjoy our many benefits and incentives including: ~ Affordable Medical/Dental/Vision plans ~ Flexible Spending Account ~ Generous Paid Time Off ~ Whole Health & Wellness Reimbursement...

24 Seven Talent

Graphic Designer Job at 24 Seven Talent

 .... Design packaging (primary components and secondary cartons) across a range of product families, including new launches and 3D renderings. Ensure packaging aligns with brand guidelines, meets regulatory requirements, and appeals to consumers. Edit and add typography... 

SZ PM Consultants, Inc.

Night Shift Construction Inspector Job at SZ PM Consultants, Inc.

 ...any deviations or non-compliant work Perform inspections across multiple disciplines: Systems/Electrical (including power and low-voltage installations), Structural components and Mechanical systems Coordinate with construction teams, project engineers, and stakeholders... 

Westmoreland Mining LLC

Director Environmental and Regulatory Affairs Job at Westmoreland Mining LLC

 ...Position Summary Director of Environmental & Regulatory Affairs reports to the Chief Operating Officer for US Operations. This role provides strategic direction for the environmental performance of WML by developing, implementing, and monitoring environmental strategies...