Senior Manager, Regulatory Affairs

San Diego, CA

  • Samumed is looking for an experienced individual to join its team as a Senior Manager, Regulatory Affairs. 
  • The Senior Manager, Regulatory Affairs will be responsible for providing regulatory strategy for all Samumed development programs, working closely with cross-functional team members to prepare timely regulatory submissions.

Specific Responsibilities

  • Providing regulatory strategy to cross-functional product development teams
  • Preparing regulatory submission documents, including writing and critical review
  • Leading submission of regulatory applications (IND/CTA, NDA/MAA) and briefing documents, and maintaining approved applications (e.g., IND Annual Reports)
  • Managing regulatory project submission timelines
  • Providing regulatory support to clinical operations (e.g., reviewing clinical trial site essential documents) and other functional areas as needed
  • Performing research to identify new/emerging regulations/policies/guidances that may impact development programs and communicating to management and project teams
  • Supporting regulatory compliance activities
  • Developing and maintaining internal regulatory processes and procedures

Requirements

  • Bachelor’s degree in life sciences or other relevant scientific discipline (PharmD or PhD preferred; RAC certification a plus)
  • Minimum 6 years of direct regulatory experience in the biotech or pharmaceutical industry
  • In-depth knowledge of FDA regulations and guidances and the general regulatory environment (experience with other agencies such as EMA and PMDA a plus)
  • Clear record of accurate and ultimately successful regulatory submissions
  • Demonstrated ability to work effectively in a cross-functional team-based environment
  • Detail-oriented with well-developed organizational and analytical skills
  • Demonstrated excellent written and oral communication skills

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.