- Full-time permanent position
- Hybrid working - 3 days WFH, 2 days office (Surrey)
- Competitive package
- Global pharma company
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
- 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.
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email email@example.com
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Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.