Regulatory Compliance Executive
2 weeks ago
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. The position involves supporting the activities within the Regulatory areas of the company including drug safety and licensing of medicines.
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. Graduate in a Science based subject. Minimum of 2 years experience in Pharmaceutical Regulatory affairs.
Ability to work well both alone and as part of a team.
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.
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 are committed to investing in our people and infrastructure which enable us to be highly flexible, efficient and innovative in our services to Clients.
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