Director, Regulatory CMC - Gene Therapy
Florida - United States
Seeking a highly experienced and driven Regulatory CMC leading professional to join a small and well-reputable, clinical-stage biotech company. We are looking for a highly qualified and confident CMC leading subject matter expert to head up this function; work closely with internal and external manufacturing providers and effectively lead the teams with the development, management, and all executions of the CMC strategies for advanced Gene Therapy programs, from Pre-clinical to Clinical to Commercial. This role will offer you the opportunity to work alongside impressive industry professionals while utilizing the company's very sophisticated and novel manufacturing technology platform.
- Gather all information, then develop, create and execute the development, lifecycle management, and maintenance for the CMC submissions for all global markets while ensuring diligence, objectives are met, all sections thoroughly completed with accurate data in a timely fashion.
- Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership and expertise within Regulatory and cross-function teams for the assigned biological products.
- Establish Regulatory CMC strategy executions to ensure compliance of CMC requirements with established regulations, guidelines, and industry; lead these strategies and share all concepts with the team.
- Strong familiarity with US and Global regulatory guidelines for biopharmaceutical products; direct interactions with global regulatory agencies for CMC submissions and CMC-related issues & activities; FDA, EMA, and ICH guidelines.
- Address and resolve CMC regulatory issues arising in pre-clinical, clinical, and commercial development programs.
- Direct experience assembling Regulatory applications in eCTD format. Utilize electronic systems for dossier creation and tracking.
- Hands-on Regulatory CMC and SME to liaise for CMC-specific regulatory documents and submissions, via eCTD, i.e.: INDs/CTAs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Amendments, Supplements, Annual Reports, regulatory briefing books (BB), annual update (IB), etc.
- Review and provide regulatory assessments on Change Controls measures for global impact.
- Ensure global regulatory requirements and strategies are understood and communicated by project teams.
- Facilitate and manage all contacts and procedures to allow for a streamlined and organized compliance partnering with external regulatory agencies.
- Delivery of all regulatory goals and objectives through product development.
- Bachelor of Science degree in life sciences or in a Scientific discipline required (Advanced degrees highly preferred)
- 10 years' experience of Regulatory CMC within a biotech/pharma setting.
- 6 years' experience working the CMC/manufacture and control of biologic drug products; Biologics experience is a must.
- Cell and Gene Therapy products experience.
- Strong knowledge of FDA, EMA and ICH guidelines requirements for biologics products
- Strong knowledge of USP guidelines.
- Regulatory CMC Technical Writing experience required; must have authored CMC sections.
- Successful track record of leading teams & key complex programs; direct interactions with the teams cross-functions has had direct reports and prior leading responsibilities.
- Strong ability to prioritize and manage multiple advanced projects at any given time.
- Demonstrated effective leadership and exceptional interpersonal and negotiating skills.
- Ability to work and think strategically within a complex, business-critical, and high-profile development program.
- Ability to identify regulatory risks and potential issues with strong expertise in the understanding of global regulations and guidance.
- Manage and prioritize multiple complex projects independently.
- Experienced in lifecycle management for biologic-specific drugs.
- Very strong understanding of cell biology, and biologics development (change management experience)
- Key skills: Excellent communication skills, both written and verbal communication, excellent organizational skills. Professional, proactive demeanor, and team player attitude. Must have strong leadership and management skills, and negotiation and presentation skills.
If interested in learning more, please contact me at firstname.lastname@example.org or (646) 430-1191 for more information.