Senior Regulatory Affairs Associate

  • Location

    London, England

  • Sector:

    Life Sciences

  • Job type:

    Blijvend

  • Salary:

    Negotiable

  • Contact:

    Denise Saab

  • Contact email:

    Denise.Saab@volt.eu.com

  • Job ref:

    75477-PHARM-DEB_1577115586

  • Published:

    10 maanden geleden

  • Expiry date:

    2020-01-22

  • Startdate:

    12/01/19

Our client is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.
We are seeking a full-time Regulatory Affairs Associate who will work on a team to accomplish tasks and projects that are instrumental to the company's success.


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


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.
*This position may require supervision of junior level staff.