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Director, Regulatory Affairs

Cambridge, MA

Posted: 01/07/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2431

Job Description


Our client is looking to add a Director of Regulatory Affairs to their team on a permanent basis.

Responsibilities:
  • Develop content, format, timing and execution of all regulatory submissions and related supplements and amendments;
  • Advise project teams regarding the development and implementation of robust regulatory strategy through the clinical development processes; identify potential areas of regulatory concern and respond to new government/regulatory developments;
  • Develop and ensure implementation of long- and short-term global regulatory strategies for company’ s pipeline drug candidates;
  • Establish and maintain excellent relationships with regulatory agency personnel; respond to requests for additional data;
  • Ensure communications from Health Authorities are disseminated in timely manner and properly interpreted to the project teams and to senior management;
  • Review and approve technical data; verify accuracy of clinical data and execution of clinical projects to regulatory authorities;
  • Develop, implement, and review current policies and practices in compliance with federal and international regulatory agencies;
  • Serve as regulatory affairs point person to provide input on trials and filing activities and to ensure that report systems are maintained and compliant;
  • Monitor regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact;
  • Review all external materials for regulatory compliance;
  • Serve as overall global regulatory lead accountable for all regulatory aspects of assigned project(s), including development and implementation of the global regulatory development plan for the project;
  • Represent Regulatory Affairs on cross-functional project teams;
  • Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives;
  • Provide regulatory due diligence assessments of new business opportunities;
  • Develop and present regulatory strategy information at senior management meetings.

Requirements / Qualifications:
  • A Master of Science in Biology; Pharmacy; Regulatory Affairs for Drugs, Biologics and Medical Devices; or a closely related field
  • 5 years of experience in a regulatory affairs-related occupation. Experience must include the following, which may be gained concurrently:
    • 5 years of experience in the pharmaceutical industry;
    • 4 years of experience in project management;
    • 2 years of experience working with multi-faceted project teams;
    • 2 years of experience working with FDA and ICH regulations and guidelines;
    • 2 years of experience working with small-molecule drug development programs;
    • 2 years of experience working with oncology programs;
    • 2 years of experience working as an FDA liaison;
    • 2 years of experience reviewing and synthesizing reports and other documents used in regulatory planning and submissions; and,
    • 1 year of experience developing and implementing regulatory strategies.

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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