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 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.
* 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 Affairs
* Experience 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.