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Manager/Sr. Manager, Regulatory Strategy - Infectious Disease

Cambridge, MA

Posted: 06/12/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2600

Job Description

Our client is seeking a Manager/Sr. Manager of Regulatory Strategy to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as an unprecedented new drug modality. The Manager/Sr. Manager will provide regulatory support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the submissions and approvals of INDs, marketing applications, and other regulatory submissions (orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.).

  • Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, PRIME, BTD applications, DSURs, MAA/BLA/NDA, etc.).
  • Works with RA-Strategist and project teams regarding the development and execution of regulatory strategy through the clinical development processes.
  • Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
  • Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Contribute to and maintain the Core Data Sheet and support global labeling team meetings.

  • BA/BS degree in a scientific/engineering discipline required, Masters or PhD preferred.
  • 5+ years of experience in the Pharmaceutical industry
  • 3+ years of experience in Regulatory strategy, including specifically: Infectious Disease and Vaccine Development
  • Strong knowledge of current US and EU regulations, including vaccine regulatory pathways.
  • Strong experience with CTD format and content regulatory filings
  • Exceptional written and oral communication
  • Experience with developing and implementing gap analysis and related competitive regulatory strategies
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance--preferably from at least both US and EU
  • Ability to work both independently and within project teams, committees, etc. to achieve group goals.
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Knowledge and understanding of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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