Regulatory Affairs Manager

3 weeks ago

manchester, United Kingdom Carrot Recruitment Full time
Job Description

Regulatory Affairs Manager – Leading Pharma Specialist Medicines – Manchester (hybrid working) - £competitive salary, 10% bonus, pension + other benefits.

Please note: 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.

The Company

Leader in specialist medicines for childrenOffices 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.Operate mainly on a UK/EU basis however there is some US exposure as well.Active pipeline within CV, Immunology and Neurology as well as an exploratory pipeline in Gastro and Oncology. The Role 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 You 5 years' experience (or equivalent) working in Pharma Regulatory AffairsExperience of the centralised procedure for new products (EMA).Working knowledge of the Common Technical Document (CTD).Experienced in directly dealing with Regulatory agencies.Experienced in scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.

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