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Assoc. Director/Director, Regulatory Strategy, Infectious Disease

Cambridge, MA

Posted: 06/12/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2601

Job Description


Our client is seeking an Assoc. Director/Director of Regulatory Strategy to support infectious disease programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as unprecedented new drug modality. The Assoc. Director/Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.

Responsibilities:
  • Develops content, format and accountability for regulatory submissions and related supplements and amendments.
  • Advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
  • Establishes and maintains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company' s filings.
  • Works on the development and submission of BLA/MAAs.
  • Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
  • Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
  • Partners with internal teams and client partners to develop content and manage submissions to regulatory agencies.
  • Serve as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project
  • Represent Regulatory Affairs on cross-functional project teams
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.
  • Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate.
  • May be responsible for line management and development of direct reports in the future.

Requirements / Qualifications:
  • BA/BS degree in a scientific/engineering discipline required, Masters or PhD preferred.
  • 10+ years of experience in the Pharmaceutical industry
  • 8+ years of experience in Regulatory strategy, including specifically: Infectious Disease
  • Strong knowledge of current US and EU regulations, including specifically: e.g. vaccine development regulations and registrations pathways.
  • Strong experience with CTD format and content regulatory filings
  • Exceptional written and oral communication
  • Experience with developing and implementing competitive regulatory strategies
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio
  • Experience dealing with broad range of stakeholders at all levels internal and external to the company
  • 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
  • Direct experience of leading regulatory authority meetings in different phases of drug development
  • Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

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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