W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9qagfybwegugfydg5lcnmgl2pwzy9iyw5uzxitzgvmyxvsdc5qcgcixv0

Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer

  • Location

    Berkshire, England

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    21032_1594737696

  • Published:

    3 months ago

  • Expiry date:

    2020-08-13

  • Consultant:

    #

Job title: Senior Regulatory Affairs Officer

A global Pharmaceutical business in Berkshire are seeking a Senior Regulatory Affairs Officer. In this role you will maintain marketing applications, develop submission strategies and gain marketing authorisations for new countries. Working in a small team you will report directly into the Senior Regulatory Affairs Manager - giving you great opportunity to learn and develop your career within Regulatory Affairs.

Responsibilities:

  • Prepare, submit and coordinate national Marketing Authorisation Applications
  • Gain marketing authorisations for pharmaceutical products in new countries
  • Compile regulatory documents in eCTD format
  • Develop submission strategies for all CMC and safety changes
  • Development and maintenance of regulatory Standard Operating Procedures

Requirements:

  • Experience dealing with multiple health authorities
  • Degree in life sciences
  • Experience submitting new MAAs
  • Previous experience maintaining existing marketing authorisations

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 Matt Thomas via matt.thomas@pharma-partners.co.uk