Director CMC RA Boston MA by icf1n7h

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									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.

Responsibilities
    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
       issues
    Mentor and coach junior regulatory staff and other team members

Requirements
   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
      distributed
   Proven leadership and management skills of cross-functional teams as well as motivational
      skills
   Excellent interpersonal and communication skills
   Negotiating and influencing skills
   Ability and willingness to travel internationally

								
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