Regulatory Affairs Senior 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

• Define regulatory strategy and provide guidance on regulatory requirements for new product development
• Scientific advice preparation and meetings, review and submission of generic, hybrid and full MAs to European health authorities through National, CP, DCP or MR procedures.
• Support the lifecycle management of existing products.
• Establish & update key processes within the RA function in Europe.

You

Ideally you will have experience in the following;

• Regulatory Strategy: Deep understanding of European regulatory requirements, with experience in developing regulatory strategies for both generic and specialty products in the EU
• Leading regulatory processes from strategy design to marketing authorisation (MA).
• Lifecycle Management: Managing product lifecycle activities, including marketing authorisation submissions, post-approval line extensions, variation strategies, and regulatory approvals (e.g., DCPs, MRPs).
• Proven track record in managing regulatory procedures to secure timely product approvals.
• Broad understanding of the EU market placement requirements.

What should you do next?

This Regulatory Affairs Senior 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.