CMC Regulatory Affairs Manager (Remote)

Contract: Thousand Oaks, California, US

Salary: $55.00 Per Hour

Job Code: 347260

End Date: 2024-05-19

Days Left: 15 days, 20 hours left

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!


Pay Range - $50 to $55/hr. (negotiable)


Job Description:
Job Roles & Responsibilities:

  • 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.

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
Job Requirement
  • Regulatory Affairs Manager
  • CMC Regulatory Affairs
  • CMC
  • submissions
  • regulatory submissions
  • regulatory documents
  • product development
  • product manufacturing
  • Biotech
  • Biotechnology
  • Pharma
  • Pharmaceuticals
  • Drug Development
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
  • 4255231648
Apply Now
Apply Now
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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