Regulatory Affairs Lead UK & Ireland

Job Description:

Regulatory Affairs Lead, UK & Ireland

At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.

Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging, and rewarding careers - we are motivated to make a difference. To reach our full potential, we collaborate, and respect and value diverse contributions so that we can grow as an organisation and as professionals. Together we can influence the world around us to make life and work better.

You will

1. Formulate sound regulatory strategies for products in the assigned therapeutic area(s) to support business goals.
2. Execute regulatory strategies by overseeing and supporting RA activities of products in the assigned therapeutic area(s) to ensure regulatory compliance and fast registrations.
3. Implement and provide the services of Global Electronic Regulatory Platform (GeRP) according to global and regional processes.
4. Support RA in achieving the pre-assigned milestones.
5. Manage a team of regulatory officers/managers and ensure their continuous development (hard skills and soft skills).

Your day at Ferring

1. Coordinate and oversee regulatory activities in UK and Ireland to implement regulatory filings as required to support business objectives and the overall compliance. Provide regular updates to the relevant business units as required.
2. Implement and provide services of Global Electronic Regulatory Platform according to the agreed roll-out schedule.
3. Ensure the development, implementation, and compliance of relevant SOPs for Regulatory Affairs. This includes contribution to improve RA processes at regional and local level.
4. Participate in global/regional projects.
5. Assess registration dossiers and variation packages at regional level.
6. Keep current with the local and international medical/pharmaceutical legislation and operation procedures.
7. Provide training to RA personnel and answer questions relating to global and regional processes, including Global Electronic Regulatory Platform and other company electronic systems.
8. Oversee the regulatory information in REGISTER to ensure that the data reflect the current registration status for products in the assigned therapeutic area(s).
9. Support the implementation of Pharmacovigilance requirements in the UK, such as maintenance of the UK PSMF and provide timely responses to MHRA PV communications.
10. Analyze data in REGISTER to monitor regulatory activities and assess KPIs in the region.
11. Prepare regular reports for accomplishments, ongoing projects, and future submissions.
12. Provide support for Regulatory Affairs in Malta.
13. Undertake Deputy Local Safety Officer responsibilities for UK and Ireland (including Malta).
14. Undertake Deputy Local Complaints Coordinator responsibilities for the UK.
15. Undertake Deputy Recalls Coordinator responsibilities for UK, and for Ireland (including Malta) as required.
16. Support Inspections of Ferring by local Health Authorities.

Required Education/Qualifications/Skills:

1. Bachelor in life sciences.
2. At least 6 years of regional regulatory affairs experience.
3. Knowledge of international guidelines and national legislation related to drug registration and Pharmacovigilance.
4. Capable of developing and implementing regulatory strategy.

If our mission and your vision are aligned, please apply!

We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.

Location: Ferring UK