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Sr. Director, Regulatory Strategy, Infectious Disease/Vaccines

Cambridge, MA

Posted: 06/12/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2599

Job Description


Our client is seeking a Sr. Director of Regulatory Strategy to support Infectious Disease programs and to be based in its Cambridge, MA headquarters. This role is intended for a forward-looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA infectious disease vaccines as an unprecedented new drug modality in the U.S. and other markets.

The Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans for assigned programs. As an expert within Regulatory, the person in this role will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate. Prior regulatory experience with infectious disease vaccines preferred.

Responsibilities:
  • Develops content, format and accountability for regulatory submissions and related supplements and amendments.
  • Monitors regulatory developments related to mRNA platform with focus on vaccines and 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.
  • Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.
  • Serves as regulatory affairs leader to provide input on trials and filing activities and to ensure that document systems are maintained and compliant.
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
  • Reviews all external materials for regulatory compliance.
  • Partners with internal teams and partners to develop content and manage submissions to regulatory bodies.
  • 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 Regulatory Affairs the 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.
  • Identify areas in need of improvement and lead the development and implementation of process improvements.
  • Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.

Requirements:
  • BS, MS, PharmD or RN and minimum of 10 years' regulatory experience in Biotech, Pharma or Clinical Research Organization.
  • Knowledgeable of relevant FDA, EU, ICH guidelines and regulations and recent regulatory guidances and changing practices relevant to Infectious Disease vaccine programs.
  • Experience with regulatory filings to the FDA, including IND amendments, meeting requests
  • Experience working with CROs, vendors, and relationship management preferred.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’ s critical regulatory milestones.

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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