Your mission

Sr. Director - CMC Lead

Pierre Fabre, the second-largest private French pharmaceutical group and the world's second-largest dermo-cosmetics lab offers you a dynamic, purpose-driven career.  

Primarily owned by The Pierre Fabre Foundation, a government-recognized public-interest foundation, we take pride in our expertise in oncology. 

Beyond being employees, we act as entrepreneurs, and our work is a pursuit of purpose and performance. Join us in our mission to protect and preserve the health and sustainability of all people and our planet. Innovate, collaborate with healthcare professionals, and make a difference with "New Ways to Care."  

Join Pierre Fabre Pharmaceuticals to make a real impact in people's lives. Your purposeful career begins here. 

SUMMARY: 

The Sr. Director - CMC Regulatory Directoris an experienced Regulatory CMC resource with specialized knowledge in complex gene or cell therapy. He/she provides the strategy and knowledge needed to ensure that CMC practices are carried out in accordance with the requirements of the FDA. 

The CMC Regulatory Director is responsible for defining and executing the overall CMC strategies to support Pierre Fabre Pharmaceuticals products through all stages of a product’s lifecycle, from development and manufacturing to licensing and commercialization for the US territory. This may include but is not limited to Biologics License Application, HA responses & background packages & post-approval submissions, as well as evaluation of potential assets to support Business Development.

To fulfill this mission, CMC Regulatory Director will assemble and lead project teams based on the project needs and the respective development stage of the project. He/she has responsibility for the overall CMC strategy and status of the project with respect to budget, timeline, achievement of defined milestones and overall project risk management for the US territory. He/she will assess project issues and develop resolutions to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. In this role, the CMC Regulatory Director will partner with global regulatory, Technical Operations and with key stakeholders.   He/she is responsible for communicating to Regulatory VP regarding the activity status and potential critical issues.

ESSENTIAL FUNCTIONS:

• Lead and develop balanced risk-based regulatory CMC strategies for US marketed products. Proactively contribute to and influence product development and life-cycle management. For investigational products, he/she will contribute to the CMC strategies for the US territory.
• Effectively manage regulatory CMC aspects of projects, under of FDA’s requirements, including the preparation and submission of CMC sections of dossiers supporting clinical trial applications, annual reports and marketing applications
• Identify potential risks to submission plans and propose risk mitigation strategies
• Ability to represent RA CMC in cross-functional forums with Manufacturing, Quality, Supply Chain, etc. in collaboration with Corporate RA CMC
• Leads the preparation of CMC documents in response to FDA or Agency requests for information, meeting briefing books to support interactions
• Ensure CMC documents meet regulatory requirements,
• Liaise with internal customers to determine key performance and compliance indicators
• Ensure tracking and archiving of regulatory communications and submissions
• Develop internal CMC work instructions and SOPs as needed

REQUIRED EDUCATION AND EXPERIENCE:

• 10+ years of highly relevant pharmaceutical /biotechnology experience in Regulatory Affairs in both early and late stage development programs
• Cell and Gene Therapy experience preferred
• Bachelor’s degree (advanced degree preferred), in Life Sciences/Health Related field
• Extensive knowledge of IND/NDA/ and CMC guidelines
• Experience in working with vendors in support of regulatory submissions
• Knowledge and understanding of applicable global regulations is required
• Excellent attention to detail and solid computer and organizational skills required
• Strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
• Proficient in collaborating across global teams, prioritizing multiple tasks and projects, and consistently demonstrating discretion and professionalism

WORK ENVIRONMENT:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.