Regulatory Affairs Associate

2 weeks ago

London, United Kingdom Apex International Recruitment Ltd Full time

Job Description

Regulatory Affairs Associate

DETAILS:

  • Full-time permanent position
  • Hybrid working - 3 days WFH, 2 days office (Surrey)
  • Competitive package
  • Global pharma company

THE ROLE:

Objective / Purpose of Role

To support the Regulatory Affairs function of the Operations department, carrying out a range of tasks supporting the fulfillment of responsibilities of the Marketing Authorisation Holder for the product portfolio, working with Quality Assurance, Medical Affairs, and external contractors.

Key Activities / Key Responsibilities

  • Support the preparation and review of regulatory applications such as variations, change of ownership applications, renewals in the UK, EU and globally Regulatory compliance tracking
  • Regulatory filing and administration
  • Communication of regulatory changes internally and externally
  • Generation, review and implementation of Product Information (Summary of Product Characteristics, leaflets and labelling)
  • Review and processing of certificates of analysis for received product batches
  • Review of stability reports, annual Product Quality Reviews, SOPs, other technical documents and change controls
  • Review and support updates to product Artwork
  • Handling Product Quality Complaints

Full job description available on application

THE CANDIDATE:

  • Degree in Pharmacy, Chemistry, Pharmaceutical or life sciences
  • Life Science industry, e.g. regulatory affairs function.
  • Minimum 1 year UK regulatory experience - ideally experience in variations, labelling and artwork changes

* Please note that only candidates currently living in the UK with Right To Work in the UK in place will be considered.

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