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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_1551701446

  • Published:

    8 months ago

  • Expiry date:

    2019-04-03

  • Start date:

    ASAP

  • Consultant:

    #

Our client is a scientifically-driven, global, full-service clinical contract research organisation (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

The company offer a fantastic package
Pension - 3% by employee, matched by employer up to 6% - 8% for managers
25 days holiday + bank holidays and the days over Christmas.
Life Assurance x4 times base salary
Private medical insurance
Season ticket loan
Eye test contribution of up to £25, with a contribution to glasses of up to £50.
Free onsite gym between 7am - 8pm inc swimming pool.
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
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.