Senior Manager – Regulatory Affairs CMC

San Francisco, CA

12+ Months

$100/HR on W2

*****CANDIDATES SHOULD BE LOCAL AND ABLE TO WORK ON OUR W2*****

Requirements:

• Education: BA/BS degree in life science in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline. Advanced degree (M.S., Ph.D., or Pharm.D.) is a plus.
• Manager Level: Minimum7+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Senior Manager Level: Minimum 10+ years of relevant experience.
• Direct experience with early and late-stage drug development.
• Strong knowledge of global CMC regulatory requirements and guidelines (e.g., FDA, EMA, ICH, Health Canada, et al) on small molecules and biologics in the US, Canada and/or Europe.
• Experience in authoring and reviewing CMC regulatory documents for regulatory submissions.
• Scientific knowledge in small molecules and biologics, ADC experience is a plus.
• Prior participation in regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Pre-NDA/BLA) and experience interacting with health authorities and leading the relevant subject matter experts to respond to agency inquiries.
• Ability to interpret complex scientific data and apply it to regulatory strategies.
• Strong project management, communication, and leadership skills with the ability to work in a fast-paced, matrixed environment.