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

The Company

Market leader in specialist medicines for children

• Stylish 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

• Ideally 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).

• Experience of directly dealing with Regulatory agencies.

• Experience of scientific advice, paediatric (Paediatric Investigation Plan) or Orphan procedures is highly desired but not essential.

• Experience in gaining and maintaining product licences in the USA is desired but not essential.

What should you do next?

This Regulatory Affairs Manager role is one not to be missed; it encompasses the opportunity to work with a hugely innovative pharmaceutical company. To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.