Regulatory CMC Director – Remote

This San Diego biotechnology company is focused on novel biological and drug delivery technologies.  They are seeking a Regulatory CMC Director that can develop and execute on regulatory CMC strategies for assigned partner programs, and manage junior-level staff. You will work closely with cross-functional teams to ensure the timely submission of regulatory filings for investigational products, marketing applications, and post-approval changes.  This is a remote role with some occasional travel. This is an exciting opportunity to broaden your experience across clinical, non-clinical, and CMC regulatory in a fun, dynamic, and patient-focused organization!

Responsibilities:

  • Contribute to and execute on regulatory CMC strategies for a portfolio of partnership programs including development and approved products.
  • Work directly with biopharma partners on regulatory issues.
  • Plan, write and review DMFs and CMC sections for INDs, CTAs, NDAs, BLAs, amendments, and life-cycle management submissions.
  • Conduct post-approval CMC regulatory activities such as change controls, etc.
  • Provide regulatory support and advice for internal and external customers in line with defined regulatory plans and in response to ad-hoc questions.
  • Conduct external and internal audits, document control, release of products, management reviews, complaint management, inspection liaison, annual reviews, and validations.
  • Manage a small team of direct reports and serve as a key member of the management team.
  • Participate in identifying and implementing the tactics necessary to achieve timely submissions and product approvals and maintain a positive quality profile .

 

Requirements:

  • BS. in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • 8+ years of experience in Regulatory CMC for pharmaceutical drugs and/or biologics.
  • Experience writing and managing DMFs and CMC sections of INDs, CTAs, BLAs, and/or MAAs for biologic programs.
  • Experience with life cycle management and post-approval CMC changes.
  • Global regulatory experience a plus but not required.
  • Solid knowledge of FDA, EMA and ICH CMC guidelines and regulations and current Good Manufacturing Practices (cGMP).
  • Experience in supervising junior staff and supporting their development preferred, but not required.
  • Energetic person with ability to prioritize and work on multiple projects at the same time.
  • Strong oral and excellent written communication skills.
  • Creative approach to problem solving; ability to deal with ambiguity and define a clear path forward.
  • Strong organizational skills and attention to detail.

 

 

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