Director, Regulatory CMC

San Diego, CA

  • Samumed is looking for a Director Regulatory CMC to join our Regulatory Affairs team.
  • The Director Regulatory CMC is responsible for providing the regulatory leadership for all development (and ultimately commercial) products, including CMC‑related regulatory strategy, application preparation and maintenance, and interaction with regulatory agencies.

Specific Responsibilities

  • Providing strategic guidance on global regulatory CMC requirements to senior management and cross-functional project teams
  • Providing guidance to senior management, key stakeholders within CMC areas, and cross‑functional project teams on all regulatory issues for the strategic planning, development, risk assessment, and compilation of regulatory submissions
  • Authoring or managing preparation of CMC‑focused regulatory submissions
  • Leading CMC-related interactions and negotiations with regulatory agencies in all pertinent countries, during all stages of development and registration
  • Serving as Regulatory CMC liaison with partner companies and contract manufacturers
  • Partnering with Quality Assurance and Product Development to ensure regulatory submission accuracy and compliance
  • Managing regulatory consultants and contractors

Requirements

  • Qualifications: Bachelor's or Master’s degree in life sciences (PharmD or PhD preferred)
  • Minimum 10 years of Regulatory CMC experience in the biotech or pharmaceutical industry
  • Familiarity with all pertinent regulations and guidances
  • Experience with regulatory submissions (IND, CTA, NDA, MAA, etc.) in eCTD format
  • Experience authoring/editing regulatory CMC and other technical documents
  • Excellent written and oral communication and interpretive skills
  • High attention to detail, and excellent proofreading and editing skills
  • High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
  • Good knowledge of the overall drug development process
  • Experience with small molecule drug development is preferred
  • Demonstrated ability in project management, with overlapping priorities and aggressive timelines

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.