• Interpret global regulations and guidance to identify risks and provide strategic guidance to cross functional product teams.
• Develop CMC regulatory strategy for early-stage cell therapy products through late stage and product registration.
• Represent CMC regulatory affairs on product teams and in health authority interactions.
• Lead development and compilation of Quality modules for global regulatory submissions including but not limited to clinical trial applications, health authority responses and briefing packages.
• Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
• Lead the build out CMC regulatory organization to support expanding cell therapy pipeline.
• Serve as a strong partner to the Development and TechOps organizations.
• Perform other duties as required.
• Hire, lead, managing workflow and develop of staff.
• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, manage/prioritize multiple projects, and work independently.
• Advanced leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.
• Outstanding organizational skills with the ability to multi-task and prioritize.

• BA/BS degree in life sciences required
• 8-10 years of experience in CMC Regulatory Affairs
  • Experience in cell therapy preferred
• Knowledge of global CMC regulations
• Experience leading CMC teams in IND, IMPD, BLA, MAA filings

Please send resumes to gavin@biophaseinc.com and visit our website at www.biophaseinc.com for additional job opportunities!!!