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Associate Director/ Regulatory Affairs

Associate Director/ Regulatory Affairs

  • Location

    London, England

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    73476-PHARM-DEB_1564671880

  • Published:

    3 months ago

  • Expiry date:

    2019-08-31

  • Start date:

    ASAP

  • Consultant:

    #

We are seeking a full-time Regulatory Affairs Associate Director who will work on a team to accomplish tasks and projects that are instrumental to the company's success.
Main responsibilities:

  • Project management focus to facilitate full global regulatory submissions

  • Providing regulatory advice and guidance to other company department to ensure compliance with EMA regulations and requirements

  • Interaction with EMA and other regulatory agencies;

  • Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA

  • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

  • The role would suit an individual who has experience of working in a cross-functional, global supply organisation.

 

  • Developing, tracking, compiling, and maintaining full regulatory applications

  • Providing regulatory advice and guidance to Sponsors and other company departments to ensure compliance with UK and European regulations and requirements;

  • Developing scientific and regulatory briefing documents for meetings with the EMA;

  • Interaction with EMA, MHRA, and other regulatory agencies;

  • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.


This is an office-based position in one of the following locations: London or Munich.

Qualifications

  • Bachelor's degree and significant (at least 8 years' experience) regulatory affairs experience;

  • CMC experience preferred

  • Experience with EMA and other regulatory agencies is preferred;

  • Strong computer skills, project management skills, and a high attention to detail;

  • Strong communication skills (both written and oral); and

  • Must be a team player with a global regulatory mindset.