Principal Regulatory Affairs Officer

CK Group are recruiting for a Principal Regulatory Affairs Officer to join a global pharmaceutical company with well known brands at their site based in Hertfordshire on a permanent basis.

The Company:

Our client offers a global portfolio across a range of therapeutic areas.

Salary: £65,000

Location:

This role is located in Hertfordshire and is a hybrid role requiring 1 day a week on site

Principal Regulatory Affairs Officer Role:

Your main duties will be:

• Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply and the compliance of all products.
• Manage & coordinate the DCP / MRP process, including leading launch meetings, estimating product approval times, liaising directly with Agencies as Subject Matter Expert.
• Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
• Support the Regulatory Manager through participation in or leadership of project teams and in the development of strategies for regional initiatives.
• Support junior team members by reviewing data intended for submission and provide advice on deficiencies and issues, and in the preparation of regulatory strategies for new marketing authorisation applications / post-approval submissions.

Your Background:

• Educated to BSc level or equivalent in Life Sciences or related area.
• Extensive experience in an EU Regulatory Affairs role in a Pharmaceutical company.
• Experience of full lifecycle of existing or new product registrations including strategy/planning, registrations, monitoring, post marketing approvals, through to launching in accordance with EU regulations.
• In-depth understanding of DCP / MRP processes, and able to give examples of estimating approval times and technical questions around variations and submissions.
• Excellent verbal and written communication skills.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56430 in all correspondence.