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Regulatory Affairs Manager or Associate Director - CMC

Regulatory Affairs Manager or Associate Director - CMC

  • Location

    London, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    £50000 - £70000 per annum

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    18366_1578411106

  • Published:

    9 months ago

  • Expiry date:

    2020-02-06

  • Consultant:

    #

Job title: Regulatory Affairs Manager or Associate Director - CMC

A global clinical research organisation with offices in Central London are looking to expand their regulatory team. These roles will provide full-service support for products within Phase I-IV. Experience within CMC is essential.

Responsibilities:

  • Developing and maintaining PIPs, Orphan Designations, Market Authorisation Applications and other regulatory applications.
  • Development and review of regulatory submission documents with a specific focus on CMC
  • Interaction with regulatory bodies such as EMA and MHRA.
  • Providing regulatory advice for various internal teams to ensure compliance with UK and EU regulations.

Requirements:

  • Experience within CMC is essential.
  • Knowledge and understanding of EMA and MHRA guidelines and regulations.
  • Bachelor's degree as a minimum.
  • Experience at all stages within the product life cycle.

Salary and benefits:

  • Private Medical and Dental insurance
  • Company matched pension
  • Performance related bonus
  • Competitive base salary

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk