logo

View all jobs

Regulatory Affairs Manager

Thousand Oaks, CA
Description:
Note:

100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours

Ideal candidate:
  • someone with a mixed background not just lab but manufacturing and process development.
  • This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

Title: Regulatory Project Coordinator (RPC)

Job Description:
  • Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
  • Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.
  • Ensure compliance with submissions regulatory agencies
  • Coordinate QC of regulatory documentation (e.g. briefing packages)

Basic Qualifications:
  • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:                
  • Change Control evaluation or owner
  • QA, Manufacturing or Operations background experience
  • Process Development experience for biotech products

Day to Day Responsibilities:    
  • Assess change control records supporting ATO and ESQ areas
  • Support submissions with site related documents, as requested
  • Provide support for variation process

Pay Rate  between $52 - $60/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

Share This Job

Powered by