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

K2NhdDEvMDNqYXhCSHk2UkdNanNybFNrRUE9PQ==
  • Barrington James
  • San Francisco, CA

Job Description

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

CenterWell Home Health

Occupational Therapist, Home Health Job at CenterWell Home Health

 ...Become a part of our caring community and help us put health first As a Home Health Occupational Therapist , you will: Assess/screen patient's daily living/work-related skills and develop therapeutic retraining programs with measurable objectives. Administer... 

Restore Hyper Wellness

Lead Esthetician Job at Restore Hyper Wellness

 ...Job Description Job Description We are looking for parttime to full time estheticians at our store in Newton Massachusetts, including a lead esthetician position. Restore Hyper Wellnessoffers Cryoskin/Hydrafacial services. Here is your chance to work at Restore... 

REC

Construction Technician Job at REC

 ...Description Are you looking to kickstart your career in the construction industry? Do you enjoy hands-on work and being out in the field...  ...Construction Materials Testing (CMT) Technicians no experience required, just a willingness to learn! What You'll Do:... 

Complete Dental Arts

Dental Assistant (3 days part-time) Job at Complete Dental Arts

 ...Job Description Job Description Job Summary: We are seeking a part-time Dental Assistant with general dentistry experience to join our team. The Dental Assistant will assist the dental team in providing high-quality dental care to our patients at our offices: Complete... 

Deaconess HomeCare

PT - Physical Therapist Job at Deaconess HomeCare

 ...advanced quality healthcare.\n \n \n ~ Evaluates the patient's functional status, status of all body systems as required for CMS documentation, and\n \n \n The Physical Therapist (PT, DPT, RPT) in Home Health is responsible for the assessment and evaluation...