W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9qagfybwegugfydg5lcnmgl2pwzy9iyw5uzxitzgvmyxvsdc5qcgcixv0

Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Up to £80000 per annum

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    19537_1579098296

  • Published:

    9 months ago

  • Expiry date:

    2020-02-14

  • Consultant:

    #

Job title: Senior Manager, Regulatory Affairs

A specialist, global pharmaceutical company in Berkshire are seeking a Senior Manager, Regulatory Affairs to lead and manage the Regulatory function. This opportunity will have overall responsibility for all regulatory activities across the EU and other markets.

Responsibilities:

  • Development of regulatory strategies to ensure timely approval from various regulatory bodies
  • Management of registration dossiers and submissions of MAA's across multiple territories
  • Cross functional interaction with commercial, medical information, medical affairs and pharmacovigilance teams
  • Leadership and training of employees within the regulatory affairs team
  • Lead interactions with regulatory bodies such as the EMEA and MHRA
  • Maintenance of labelling and product information to ensure compliance within guidelines

Requirements:

  • Extensive experience within the Pharmaceutical industry, Medical Device experience is desirable
  • Full product life cycle experience is essential - key focus on post approval
  • Experience of working with Regulatory bodies such as the EMEA and MHRA. Middle East and Australia/New Zealand would be a bonus
  • Previous experience of managing a product through the DCP/MRP/National approval process
  • Previous line management experience is essential
  • Life Science degree

Salary and benefits:

  • Competitive annual salary
  • Car allowance
  • Performance related annual bonus
  • Private medical insurance
  • Income protection
  • Life assurance

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