Director

Description:

My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects of their rare disease development programs, working closely with other departments. Will be onsite in the Bay Area 3x per week.

Responsibilities:

• Provide strategic and operational regulatory support for Chemistry, Manufacturing, and Controls (CMC) collaboration within project teams.
• Planning, coordinating, and developing CMC sections for regulatory submissions, reviewing protocols and reports, and ensuring compliance with regulations.
• Offering regulatory advice to cross-functional teams, leading the drafting of submission responses to regulatory queries, and collaborating with CMC and Quality departments for Scale-up and Post-Approval Changes.
• Contribute to regulatory plans, strategies, and risk mitigation is expected.

Qualifications:

• Life Sciences Degree (MSc, MPH, PhD - preferred)
• 7-10yrs of direct Pharmaceutical experience within Regulatory Affairs
• IND through Late Stage development required
• Hands on NDA experience
• Successful regulatory submissions to FDA