Regulatory Affairs Executive

1 month ago

United Kingdom Callisto Pharma Group Full time

Regulatory Affairs Executive

Due to continued expansion and new Client projects we are currently seeking an additional Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.

This position requires a minimum of two years experience working in pharmaceutical regulatory affairs with knowledge of the drug development process, eCTD Dossier preparation, submissions management, and other regulatory functions. You will have the ability to work independently with minimal supervision as well as in a team and have an eye for detail with respect to documentation.

The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines.

You will have a degree in Life Sciences, Chemistry, Applied Biology or Pharmacy, excellent communication and negotiation skills, together with the ability to work independently.

Key Duties and Responsibilities

  • Preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new licence applications, variations, PIQ submissions, responses to questions and renewals.
  • Writing sections of the Module 3 of dossiers and Quality Overall Summaries
  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. Coordination and review technical documentation.

Role Requirements

  • Graduate in a Science based subject. Minimum of 2 years experience in Pharmaceutical Regulatory affairs.
  • 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

  • Customer Focus: Manages their own activities to ensure they are focussed on delivering outstanding service to the end customer.
  • Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
  • Flexibility: Able to adapt to meet the needs of the business at any point in time.

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 including part week hybrid working available.

About Us

The Callisto Pharma Group has grown from the formation, in 2003, of Callisto Regulatory Consulting Ltd, which provided regulatory and technical support to pharmaceutical manufacturers to a group comprising of three companies that can provide a complete range of technical services across the whole supply chain to multiple regulated sectors including human, veterinary and herbal medicines, borderline products, biocides, medical devices and food supplements.

We 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.

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.

Reference ID: CAL2024-2-REG

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