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Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager

  • Location

    Hertfordshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    22770_1612974248

  • Published:

    8 months ago

  • Expiry date:

    2021-03-12

  • Consultant:

    #

Job title: Regulatory Affairs Senior Manager - 12-Month FTC

A global pharmaceutical business in Hertfordshire is looking for a Senior manager to join on a 12-month FTC. The role is responsible for life cycle maintenance of key products and providing strategic support.

Responsibilities:

  • To set objectives, deliver results and implement policies and operational targets that have a direct effect on the operational outcome.
  • Contribute to the planning, execution, and assessment of product life cycle management activities.
  • Contact with clients and external vendors to help troubleshoot routine client queries.
  • Organises resources and processes across multiple teams to develop and deliver complete regulatory submissions within agreed timeframes.

Requirements:

  • Substantial experience within Regulatory affairs and Pharmaceutical industry.
  • Proven knowledge of UK regulations including clinical trial regulations.
  • Experience in life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, and negotiating labelling with regulatory authorities.
  • Oncology experience would be advantageous.

Salary and benefits:

A highly competitive salary and wider benefits scheme is on offer

To apply for this position or hear further details then please contact Freddie Hill via freddie.hill@pharma-partners.co.uk