Regulatory Affairs Officer

Job description

Due to continued growth, we are seeking an additional Regulatory Affairs Officer to join our team in a well-established and growing Consultancy. The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines.

You would be a science graduate preferably with some work-based experience but it could be a first role for the right graduate candidate as training will be provided.

You will need to demonstrate ambition to continually develop and work effectively as part of a growing team. Please indicate your individual qualities and reasons for your interest in the role in your application.

Key Duties and Responsibilities

  • Support the preparation of regulatory submissions for medicinal products, which may include new license applications, variations, responses to Competent Authority questions and renewals.
  • Dealing with International, European and domestic regulatory agencies in relation to national, decentralised and mutual recognition applications
  • Assist in ensuring product packaging and associated information is updated and maintained in accordance with regulatory requirements, in international territories, including the review of artwork for product packaging and provision of accurate labelling translations.
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.
  • Proof reading product safety information including Summary of Product Characteristics (SPC’s) and Patient Information Leaflets (PILs), and preparation of user tests.
  • Maintain up-to-date records and documentation in relation to Marketing Authorisations.
  • Involvement with regulatory aspects of medical device products

Role Requirements

  • Graduate in a Life Science based subject.
  • Excellent verbal and written communication skills with high level of attention to detail and accuracy of work.
  • Strong organisation skills and ability to cope with large volume of work across different areas of the company with changing deadlines.
  • Ability to work well both alone and as part of a team.

Behavioural Competence

  • Eye for detail and a commitment to high standards.
  • Demonstrate critical thinking and decision making.
  • Personal accountability and effective time management.

Package Details

Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based but flexible working arrangements available.

About Us

We have grown from the formation, in 2003, of Callisto Regulatory Consulting Ltd, which provided regulatory and technical support to pharmaceutical manufacturers. Developing into a consultancy group that can provide a complete range of technical services across the whole supply chain within multiple regulated sectors including human, veterinary and herbal medicines, borderline products, biocides, medical devices and food supplements. Callisto recently joined forces with ProductLife Group in October of 2024.

As a ProductLife Group Company we continue to work across the UK, Europe, and the rest of the world for clients operating in highly regulated sectors, ranging from global multi-nationals to single product licence holders.

Within the group we provide product release and QP Technical support to manufacturers and licence holders. The group holds both an MIA and ManA granted by the MHRA to enable us to support clients wishing to import Licensed Human & Veterinary products into the UK. 

We also hold an MIA, VIA and WDA granted by the HPRA and, in conjunction with our UK licences, to maintain a European (EEA) footprint.

We are committed to investing in our people and infrastructure which enable us to be highly flexible, efficient and innovative in our services to Clients.

Apply

To apply please email your CV along with a cover letter to info@callistopharmagroup.com