Director Regualtory CMC

A rapidly growing biotech is seeking a Director Regulatory CMC to serve as an RA CMC expert and strategic leader to bring a hands-on approach to a mission-driven organization. This team is composed of world-class scientists and innovators who are leading the charge on integrating advanced imaging and AI technologies to revolutionize drug discovery

The Director, Regulatory CMC will be responsible for leading the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical products. The ideal candidate will have a strong understanding of global regulatory requirements and guidelines related to CMC, along with experience managing regulatory affairs activities within the biotech or pharmaceutical industry.

Key Responsibilities:

• Develop and execute regulatory strategies for CMC components of pharmaceutical development programs.
• Prepare and submit high-quality regulatory documentation to global health authorities.
• Serve as the primary CMC regulatory contact with regulatory agencies.
• Lead and mentor a team of regulatory professionals.
• Collaborate cross-functionally to ensure alignment with regulatory expectations and timelines.
• Stay current with evolving regulatory requirements and industry best practices.
• Provide strategic input on CMC development plans to ensure regulatory compliance.
• Support regulatory inspections and audits related to CMC activities.
• Contribute to the development of internal regulatory policies and procedures.

Qualifications

• Advanced degree (PhD, PharmD, MS) with 10+ years of relevant experience, or a Bachelor's degree with 12+ years of experience in regulatory affairs focused on CMC.
• Recent experience in small molecule drug development is required.
• Demonstrated experience authoring and compiling regulatory dossiers.
• In-depth knowledge of global CMC regulatory guidelines and submission processes.
• Proven leadership experience managing regulatory teams.
• Strong interpersonal and communication skills, with the ability to work effectively across disciplines.
• Ability to manage multiple priorities in a dynamic environment.
• High attention to detail and ability to work independently.