Regulatory Affairs Manager – Global Pharma – Berkshire with hybrid working - £negotiable DoE, bonus & benefits

The Company

My client is a global pharmaceutical company specialising in the development, production, and marketing of a wide range of pharmaceutical products. Their focus areas include Generics, Branded Formulations and Speciality Drugs covering a wide range of therapy areas on a global basis.

The Role

• Preparation, submission, and management of approvals of National, Mutual Recognition, Decentralised and Centralised Procedure applications in the region as per agreed timelines.
• Preparation, submission, and management of variation applications to agreed timelines.
• Manage and submit Renewals and support PSUR submissions in line with specified timelines.
• Management of all regulatory activities related to the UK and EU markets (including artwork approvals, maintenance of Manufacturer’s / Importer licence (MIA) etc.)

You

Ideally you will have experience in the following;

• At least 5 years’ experience in UK & EU Regulatory Affairs (Pharma or Generics)
• Experienced in National, Mutual Recognition, Decentralised and Centralised Procedure applications
• Strong knowledge of EU and UK legislation
• Respiratory experience is hugely beneficial

What should you do next?

This Regulatory Affairs Manager role is one not to be missed; it encompasses the opportunity to work with a leading Generics 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.