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Head of CMC Regulatory Affairs

2 months ago

Los Angeles, California, United States BioPhase Solutions Full time
Position Overview

BioPhase Solutions is dedicated to connecting exceptional talent with leading organizations in Southern California's scientific sector. We are currently seeking a Director/Sr. Director, CMC Regulatory Affairs for a prominent biotechnology firm in the Greater Los Angeles region.

The Director/Sr. Director, CMC Regulatory Affairs will spearhead the development and execution of the CMC regulatory strategy for innovative early-stage T-cell therapies. This role encompasses a variety of responsibilities, including crafting regulatory strategies, offering internal guidance on CMC matters, and liaising with regulatory bodies.

Key Responsibilities:
  • Analyze global regulations and guidelines to pinpoint risks and deliver strategic advice to cross-functional product teams.
  • Formulate CMC regulatory strategies for early-stage cell therapy products through to late-stage development and product registration.
  • Act as the CMC regulatory affairs representative on product teams and during interactions with health authorities.
  • Oversee the development and assembly of Quality modules for global regulatory submissions, including clinical trial applications and health authority responses.
  • Ensure that all submission documents and communications maintain the highest standards of quality in terms of content, organization, clarity, and precision.
  • Lead the expansion of the CMC regulatory organization to support a growing pipeline of cell therapies.
  • Collaborate effectively with Development and TechOps teams.
  • Fulfill additional duties as required.
  • Recruit, manage workflow, and develop team members.
  • Exhibit a proven ability to cultivate strong working relationships with cross-functional teams, participate in and/or lead multi-functional initiatives, manage and prioritize multiple projects, and work autonomously.
  • Demonstrate advanced leadership capabilities to successfully guide complex programs and effectively build and lead high-performing teams.
  • Possess exceptional organizational skills with the capacity to multitask and prioritize effectively.
Qualifications:
  • A Bachelor’s or Master’s degree in life sciences is required.
  • 8-10 years of experience in CMC Regulatory Affairs, with a preference for experience in cell therapy.
  • Comprehensive knowledge of global CMC regulations.
  • Experience in leading CMC teams through IND, IMPD, BLA, and MAA submissions.

For further information about this opportunity and others, please visit our website.