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Regulatory Affairs Officer

Regulatory Affairs Officer

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Freddie Hill

  • Contact email:

    freddie.hill@pharma-partners.net

  • Job ref:

    21486_1600421340

  • Published:

    about 1 month ago

  • Expiry date:

    2020-10-18

  • Consultant:

    #

A global Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Officer. In this role you will prepare and submit new MAs and product maintenance variations as well as ensuring the product licences in the registered markets are in compliance with Regulatory requirements. Working in a small team will give you a great opportunity to learn and develop your career within Regulatory Affairs.

Responsibilities

  • Compile and submit variations (DCP/MRP/National) in line with the variation regulations.
  • Compile and submit renewals prior to MA expiry
  • Lead Regulatory approval processes for licence maintenance and MA submissions in new market
  • Liaise with Regulatory Authorities to agree submission strategies and resolve issues

Requirements

  • Experience in handling regulatory submissions to global authorities both new application and life-cycle management
  • Knowledge of the EU and Global Regulatory requirements
  • Experience in handling regulatory submissions to global authorities
  • Degree in Life Sciences

Salary and Benefits

A competitive salary, annual bonus and private medical insurance are on offer.

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