Regulatory Affairs Specialist (UK)

About The Job
Productlife Group is seeking a motivated and detail-oriented Regulatory Affairs Specialist to join our growing life sciences company. In this role, you will ensure global compliance with regulatory requirements throughout the product lifecycle, from development and approval to post-market maintenance.

Activities will range from pre licensing activities, new registration all the way to post licensing regulatory submissions and interaction with health authorities.

ProductLife Group (PLG) is a dedicated life sciences outsourcing and consulting company. The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC. Callisto Pharma Group has provided expert consultancy across the pharmaceutical supply chain since its formation in 2003 as Callisto Regulatory Consulting Ltd. Over the years, Callisto has evolved into a multi disciplinary consultancy supporting Human, Veterinary, and Herbal Medicines, Medical Devices, Biologicals, Biocides, Borderline Products, Cosmetics, and Food Supplements.

Our team works with clients ranging from global multi-nationals to single product licence holders, delivering technical expertise from development to distribution. With extensive experience across diverse regulatory environments, Callisto focuses on delivering flexible, real world solutions that support efficient market access and ongoing compliance for companies operating throughout the UK and Europe.

The position can be based at our offices in Lockington with a hybrid working model or remotely within the UK with bimonthly travel to our offices.

Key Responsibilities

• Contribute to the production of client administrative documents and reports to be included in regulatory submissions


• Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements


• Completing and advising on regulatory activities including regulatory strategy.


• Independent preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new license applications, variations, responses to questions and renewals.


• Coordinate and review technical documentation.


• Preparation and review of user testing readability reports.


• Involvement with medical device regulatory work.


• Writing sections of Module 3 of dossiers and Quality Overall Summaries.


• Advising on technical activities relating to all product types.


• Providing technical support in the context of the regulatory framework.


• Providing general technical advice based on previous industry experience.


• Preparation of clinical and non-clinical overviews and summaries


• Support junior members of the team in their development and training.


• Document and track regulatory submissions and gain regulatory authority approval


• Assess regulation and inform the clients about the impact on their products or activities as well as liaise with external regulatory authorities as required


• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling


• Provide on-going regulatory support to the Regulatory Affairs Team Lead and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives


• Systems Management and Administration


• Review tasks for, support and mentor Regulatory Affairs Associates team members


• Provide regulatory support to clients and associate companies

Experience And Qualifications

• Bachelor s degree in Life Sciences, Pharmacy, or a related field (Master s degree or higher is a plus)


• 5+ years of relevant experience in Regulatory Affairs, focusing on UK Market ad Regulations


• In depth knowledge of UK and EU Regulatory Authorities and frameworks


• Proven experience analysing and writing regulatory documents as well as acting as liaison with the competent authorities


• Medical writing experience would be highly advantageous


• Strong knowledge of the lifecycle maintenance of medical products


• Experience providing regulatory support to clients and being the main point of contact


• Strong attention to detail and organizational skills with the ability to prioritize tasks and deliver high-quality work in a fast-paced environment


• Excellent communication skills both written and verbal