Director CMC RA Boston MA by icf1n7h


									Director, Global Regulatory Affairs Chemistry, Manufacturing, and Controls Strategy Lead US

Our client is an innovative leader in the U.S. biopharmaceutical industry with more than 1,000
employees throughout the United States & a diversified product portfolio focusing on a variety of
therapeutic areas.

    Develop global CMC regulatory strategy for development products
    Direct management of assigned small molecule development programs
    Drive all CMC submission activities (IND, CTA, NDA) and health authority interactions
       (meeting requests and briefing documents)
    Coordinate & manage pre-IND, pre-NDA, IND, & NDA meetings with the FDA
    Represent Regulatory Affairs at various project team and working group meetings
    Assess and communicate CMC regulatory requirements to ensure all development
       activities are in compliance with applicable regulations and guidelines
    Expected to develop & manage project timelines as well as have the ability to multi-task
    Monitor changes to development plans and provide regulatory guidance to teams to
       bridge changes into the clinic
    Contribute to the development of equivalency protocols, validation protocols, and
       stability protocols
    Ensure the quality and content of all submissions to health authorities
    Liaise with partnering companies to ensure regulatory alliance
    Act as direct point of contact with FDA and other regulatory authorities for CMC related
    Mentor and coach junior regulatory staff and other team members

   Degree in a Life or Physical Science or related discipline and a higher degree (PhD, MS)
   Fluent command of spoken and written English. Knowledge of a second European
      language would be an advantage
   10 or more years of US FDA regulatory experience in the pharmaceutical industry
   Proven expertise in managing FDA regulatory quality submissions and gaining approvals
   Proven expertise to develop and manage manufacturing change control strategies
   Demonstrated experience in interaction with global health authorities, especially FDA
   Business–orientated thinking
   Ability to function in a multi-cultural environment with employee base that is globally
   Proven leadership and management skills of cross-functional teams as well as motivational
   Excellent interpersonal and communication skills
   Negotiating and influencing skills
   Ability and willingness to travel internationally

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