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Regulatory Affairs Manager

Regulatory Affairs Manager

  • Location

    Hertfordshire, England

  • Sector:

    Pharmacovigilance

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    18238_1576658830

  • Published:

    10 months ago

  • Expiry date:

    2019-12-17

  • Consultant:

    #

Job title: Regulatory Affairs Manager

An independent Pharmaceutical/Medical Device business with portfolios in Aesthetics and Neuroscience is seeking a Regulatory Affairs Manager. This role will cover a wide variety of regulatory activities with close interaction with the MHRA and HPRA.

Responsibilities:

  • Preparation, maintenance and review of Product Information
  • Raisin CAPAs and deviations as necessary
  • Management of MPUK and Global (when relevant) POLs/SOPs/WIs
  • Manage the life-cycle maintenance of existing MAs
  • Working with cross-functional groups to guarantee the development of regulatory strategies match business goals
  • Managements on EQMS including the management of training modules

Requirements:

  • A minimum of 3 years' experience within Regulatory Affairs
  • Highly experienced in filing variations with the MHRA with additional knowledge of eCTD, publishing and electronic portals
  • Life sciences degree as a minimum. Pharmacy degree is desirable
  • Extensive experience within Medical Devices is desirable

Remuneration:

  • Competitive basic annual salary plus a benefits package to include annual bonus

To apply for this position please use the "Easy Apply" option or feel free to send your CV directly to the Pharma-Partners team via email info@pharma-partners.co.uk