Global Regulatory CMC Manager

Hiring By - Biostaffic

 BioPharma

Summit, New Jersey - United States

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Job Description
Your main responsibilities as a Global Regulatory CMC Manager:
  • Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
  • These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
  • Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
  • Responsible for the global regulatory evaluation of CMC change controls with supervision.
  • Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
What we are looking for in a Global Regulatory CMC Manager:
  • BS/BA degree in Scientific Discipline (Masters or higher preferred) with
  • 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
  • Experience with sterile products preferred.
  • Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
  • Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
Company Description
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Summit, New Jersey - United States

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
R&D Partners
R&D Partners

Current Openings: 0

R&D Partners is a global functional service provider & strategic staffing resource specializing in scientific, clinical research & engineering. The cornerstone of our success starts with a knowledgeable and experienced team of life science professionals. After assessing our clients' project resourcing needs, our team can deliver the appropriate workforce solution focusing on the unique skills and experience your project requires. Established in 2007, we partner with the world's leading biopharmaceutical, medical device, and diagnostic companies, focusing on their unique research & development resourcing needs. We pride ourselves as a niche life science provider partnered with the leading global healthcare & life science solutions provider Acacium Group. Parent Company: https://acaciumgroup.com/
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