Associate Director, Regulatory CMC

  • Location:Cambridge, MA
  • Department:Regulatory Affairs
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

SUMMARY:

We are seeking a motivated leader of Regulatory CMC to be responsible for the development of regulatory strategies and submissions related to the manufacturing of our products in the US and globally. The position reports to the Director, Head of Regulatory Affairs and will be responsible for the future development and growth of the Regulatory CMC function.

 

RESPONSIBILITIES:

  • Provide regulatory CMC strategic leadership to support development programs
  • Partner with cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
  • Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs
  • Serve as the Regulatory Affairs representative on CMC teams
  • Lead communications with regulatory agencies related to CMC strategies and issues
  • Manage and implement planning, authoring and submission of high-quality CMC‑related briefing documents and CMC portions of regulatory applications in the US and globally
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Monitor regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice to company leadership and CMC teams
  • Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team

 

QUALIFICATIONS:

  • 8+ years of pharmaceutical or biotech industry experience, at least 5 years experience in CMC Regulatory Affairs, spanning both early and late-stage drug development. Prior experience with monoclonal antibodies/biologics is desirable
  • Bachelor’s Degree in biochemistry, chemistry, biology or related pharmaceutical fields, Advanced degree preferred
  • Direct experience leading interactions with regulatory health authorities
  • Experience creating and submitting CTA/IND and/or BLA/MAA filings
  • Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
  • Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
  • Strong oral and written communication skills
  • Excellent time management skills with a proven ability to meet deadlines
  • Experience working in SharePoint and with Starting Point templates; experience using Veeva Vault a plus