Regulatory Affairs Associate

Location

Surrey | United Kingdom

Job description

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 fulfilment 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 support updates to product Artwork

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 - experience in variations, labelling and artwork changes is essential and ideally CEP/Module 1 changes
• Product lifecycle / post/marketing regulatory experience essential

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

TO APPLY:

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 protected]

To view our other vacancies, please visit our website on

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.

Job tags

Salary