Associate Director Regulatory Submissions

Job Ref: J31844
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Permanent
Date Added: 10 May 2019
  • Warsaw, Poland Warsaw Poland 00-001
  • Competitive
    ANNUM
  • Emanuele Giansanti
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Associate Director - Regulatory Submissions

Permanent, Full-Time, Office-Based role

Extremely competitive basic salary + excellent benefits package

Locations: Warsaw, Poland.

Following a period of rapid growth, our client (Global CRO) is undergoing heavy expansion and they are currently looking for skilled industry professionals to take on a leading role within their Regulatory Affair department in Warsaw.

The Associate Director of Regulatory Submissions is a senior, key role within the business. The successful candidate will be responsible for the direct management of other operational Regulatory Submissions managers.

Further responsibilities include:

  • Oversee the whole Regulatory Submissions process, including: tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;

  • Ensure all project and Regulatory Submission timelines are maintained accordingly;

  • Provide regulatory advice and guidance to different internal department to ensure compliance with EMA regulations and requirements;

  • Interaction with EMA and other regulatory agencies.

Requirements:

  • Life Science or Healthcare related degree;

  • Strong experience in Regulatory Submissions department within a CRO environment;

  • CMC experience preferred;

  • Experience with EMA and other regulatory agencies is preferred.WANT TO APPLY?

For an immediate consideration please press 'apply' or alternatively contact Emanuele either via email (emanuele.giansanti@srg.co.uk) or call (+44 0203 910 9516) now and get more information about the role.Our team at SRG Clinical also cover roles in Biometrics, Medical Affairs, Clinical Operations, Medical Information, Pharmacovigilance and Regulatory Affairs so do not hesitate to get in touch.

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SRG
09/06/2019 14:55:38
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