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Compliance Manager/Senior Manager - Manchester, United Kingdom - Carrot Recruitment
Description
Regulatory Affairs Manager – Leading Pharma Specialist Medicines – Manchester (hybrid working) - £competitive salary, 10% bonus, pension + other benefits.
This role is a 12month FTC to cover maternity leave. You'll be a permanent member of staff, with a salary/company benefits, for the 12 months. This is not an hourly/daily rate contract role.Leader in specialist medicines for children
Offices in Manchester city centre, they offer a hybrid working policy (2/3days per week in the office), whereby you can expect perks such a dog friendly office, wellness room and a barista service.
Provide regulatory support for all activities conducted by the Company including dossier compilation, variations, change impact assessment, scientific advice applications, paediatric investigation plans, PSUR submissions.
To manage the generation and maintenance of Registration Dossiers (MAA/CTD) related with the products manufactured, in compliance with applicable legislations.
To develop the regulatory strategy for new submissions.Working on EU projects within centralised procedures
5 years' experience (or equivalent) working in Pharma Regulatory Affairs
~ Experienced in directly dealing with Regulatory agencies.
~ Experienced in scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.