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Director of CMC-Regulatory Affairs (cGMP – Pharmaceutical – Gene Therapy) JD820705

JD820705

DPS is looking for a proven CMC Director-level resource to support a pharmaceutical client in the Boston, MA area. Ideal candidates should have previous experience supporting gene therapy and biologics technical operations. This position will be responsible for overseeing and directing all chemistry, manufacturing and controls (CMC) regulatory strategies for new and mature products. This will involve providing guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations; provide strategic input and risk assessments; oversee preparation of CMC regulatory submissions and interact with regulatory agencies. Please be aware that this role may also require occasional travel (up to 15% can be expected – including international).

Category:
Miscellaneous Personnel
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
15/06/2020
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors

Director of CMC-Regulatory Affairs (cGMP – Pharmaceutical – Gene Therapy)        JD820705

Boston, MA area

 

DPS is looking for a proven CMC Director-level resource to support a pharmaceutical client in the Boston, MA area. Ideal candidates should have previous experience supporting gene therapy and biologics technical operations. This position will be responsible for overseeing and directing all chemistry, manufacturing and controls (CMC) regulatory strategies for new and mature products. This will involve providing guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations; provide strategic input and risk assessments; oversee preparation of CMC regulatory submissions and interact with regulatory agencies.

 

Please be aware that this role may also require occasional travel (up to 15% can be expected – including international).

 

Responsibilities:

 

  • Develop overall CMC regulatory strategy for client products and lead CMC regulatory strategy discussion providing regulatory guidance to ensure compliance with applicable regulations and guidelines.
  • Oversee and lead all regulatory CMC submission for the INDs, CTAs, BLAs, and NDAs.
  • Lead CMC related interactions with the health authorities including preparation of briefing documents.
  • Anticipate consequences of new or revised worldwide regulations and guidelines.
  • Prepare, review and approve applications for consistency with appropriate guidelines and regulations. Provide appropriate guidance and develop regulatory strategies.
  • Act as a recogniz688891.992177ed expert to internal working teams, external regulatory authorities and other regulatory affairs professionals.
  • Serve as primary regulatory contact and provide direction to CROs and contract vendors as needed.
  • Verify that manufacturing activities are conducted in compliance with Federal regulations and protocol requirements.

 

Education and Requirements:

 

  • Bachelor’s degree in a scientific discipline required and advanced degree preferred.
  • Minimum of 8+ years’ experience in drug development/regulatory affairs.
  • Experience with both US FDA and EMA is required. Global experience is preferred.
  • Prior BLA and NDA experience is also preferred.
  • Experience with the regulation of biologics and small molecule drug products is essential. Experience in gene therapy would be an asset.
  • Broad understanding of the drug product development process is required.
  • Must have thorough knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH Good Clinical Practice Guidelines, and an understanding of GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211).
  • Demonstrated ability to independently review CMC related documents and reports.
  • Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.
  • Excellent interpersonal skills.
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