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Job

Senior Director Regulatory Affairs

  • Location

    REMOTE

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Fahd Joudi

  • Contact email:

    f.joudi@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    5 days ago

  • Expiry date:

    2023-07-20

  • Startdate:

    ASAP

Responsibilities

Develop global regulatory plans to facilitate the progress of programs in all phases of development; identify risk mitigation strategies and influence project teams and to maximize the likelihood of regulatory success.

Doing this well requires
 

  • Supporting efficient conduct of development programs, while maintaining compliance with ICH requirements, regional requirements, and scientific and company procedures
  • Managing regulatory documents/submissions supporting IND/CTA and marketing applications
  • Preparing for and attending meetings and teleconferences with FDA and ex-US regulatory agencies
  • Maintaining knowledge of and monitoring changes in global rules, regulations, and guidances governing drugs and biologics in all phases of development
  • Initiating and contributing to local and global process improvements
     

Preferred Skills, Qualifications, And Experience
 

  • Extensive drug development experience
  • Experience developing regulatory strategies
  • Experience preparing global regulatory submissions including INDs, CTAs, marketing applications, and meeting briefing packages
  • Experience with regulatory submissions and marketing applications in Electronic Common Technical Document format
  • Experience with regulatory inspection readiness
  • Ability to travel to agency meetings (US and international authorities)
  • Scientific background (endocrinology, oncology, neurology desirable) with 10+ years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
  • Senior management experience, ability to develop a team
  • Excellent verbal/written communication skills
  • The ability to work collegially
     

Preferred Education

  •  BA/BS degree, advanced degree preferred (MS or PhD)