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Job

Senior Director, Regulatory Affairs

  • Location

    Boston

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    29 days ago

  • Expiry date:

    2020-07-15

  • Startdate:

    ASAP

Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

Working in partnership with the Senior Vice President, Regulatory Affairs:

Responsibilities:

  • Responsible for NDA & MAA submissions
  • Provide regulatory leadership and guidance to project teams
  • Develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. 
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
  • Provide regulatory expertise 
  • Identify and assess regulatory risks for assigned projects or programs
  • Participate and contribute in Health Authority meetings
  • Develop and mentor junior Regulatory staff members

Requirements:

  • Minimum M.S. degree in life/health/technical sciences required
  • Minimum 10+ years’ regulatory experience or a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
  • A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications
  • Knowledge of global regulatory requirements
  • Experience preparing NDAs/MAAs, as well as experience within a matrix environment
  • Ability to represent the department in project teams
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements