Job title: Senior Regulatory Affairs Manager – EU
An exciting opportunity has arisen for a Senior Manager, Regulatory Affairs Europe with a leading Biotechnology business with a strong pipeline of both development and marketed assets. In this role, you will provide essential support in the planning and coordination of regulatory submissions as they continue for product launches across their International business.
Responsibilities:
- Support the Regulatory Affairs team in the timely planning and coordination of regulatory submissions for the UK initially, with support expected to extend to the EU and other International markets.
- Work to prepare national MAAs and lifecycle management submissions for the UK.
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions for assigned projects.
- Monitor the development of new regulatory requirements or guidance documents with regards to the UK, as well as EU and International countries
Requirements:
- Pharmaceutical industry experience in Regulatory Affairs
- Solid working knowledge of drug development process and post-marketing regulatory requirements for the UK and EU required
- Experience working effectively across cultures and in complex matrixed environment.
- Excellent organizational skills and highly motivated.
Salary and benefits:
A highly competitive salary, car allowance, annual bonus, private healthcare and wider benefits are on offer
To apply for this position or hear further details then please click “Apply” or reach out via email – Freddie.hill@pharma-partners.co.uk