Senior Regulatory Officer

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United Kingdom
Slough, England
Posting date: 27 Jan 2021
35266

A fantastic vacancy has become available for a Senior Regulatory Officer in Slough. This pharmaceutical regulatory affairs job is an excellent opportunity to work for a global leader in the life sciences industry.

Job Responsibilities

  • Ensure that submissions of marketing authorisations, variations, renewals, periodic safety update reports and relevant clinical trial applications are made to the regulatory authorities in a timely and professional manner.
  • Ensure updates to product information (SmPCs, PILs, Labels, Packaging) are updated in line with licence maintenance activities, and that briefings are sent to appropriate audiences, both internal and external, in a timely manner
  • Work with global regulatory colleagues in the preparation and submission of responses to regulatory authority questions
  • Manage safety updates to marketing authorisations, including management of risk management plan updates
  • Prepare, submit and follow up applications for export certificates to the MHRA and/or HPRA
  • Cooperation with other departments (medical affairs, marketing, etc.) for the purpose of obtaining / receiving / expanding and maintaining the approvals.
  • Ensure business stakeholders are informed of all relevant regulatory updates
  • Assist the market access team with Pharmascan activities, by providing regulatory timelines on request
  • Participate in the review of product prescribing information in line with the ABPI Code for the UK and IPHA Code of Practice for Ireland

Skills and Requirements

  • Life sciences or chemistry graduate to honours level or equivalent
  • Master's Degree, Post Graduate Diploma or PhD preferred
  • Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
  • Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-PD1

close