Regulatory Affairs Lead/Head Of Department

Regulatory Affairs Lead/Head of Department

Leamington Spa, UK

An opportunity to work as a Regulatory Affairs Lead for a growing pharmaceutical company that specialise in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for an experienced leader who is personable, detail-oriented, and successful in driving regulatory strategies.

The position will work with other functions such as medical and PV supporting the business where needed. Including filing all new MAA for over 45 licenses in the UK market.

Key Responsibilities

·       Full management of the UK product portfolio, MAA submissions, all deficiency responses, technical transfers, and all post-approval activities.

·       Leading all interactions with the MHRA and preparing any health authority responses.

·       Responsible for all in-licensing and out-licensing projects.

·       Financial oversight of project costs and departmental budgets.

·       Management of all external consultants and service providers.

·       Management mentoring and training of all regulatory staff.

·       Management of all pharmacovigilance and medical information activities

·       Regulatory intelligence monitoring, attending relevant conferences/seminars and scientific advice meetings.

·       Full liaison with commercial and launch management teams

Requirements

·       Scientific degree/life sciences degree with a minimum of 8 years’ experience in Regulatory Affairs.

·       Broad experience working on the UK market with previous experience leading MHRA interactions.

·       Ideally a background in generics, OTC, or prescription medicines.

·       Excellent people skills and can influence decisions at a senior level.

·       Detail drive, strategic, personable, and knowledgeable about the UK regulatory environment.

An excellent opportunity to step into a lead regulatory role and influence key decisions at a senior level, the role offers great flexibility and a chance to drive the regulatory functions for a growing business.

To be considered for this role you MUST have previous experience working at a senior level and have previous experience leading a team and driving RA strategy.

Please NOTE this role does not offer sponsorship and the right candidate will need to be based in the UK and hold the FULL Right to Work in the UK. The position requires 1 day at minimum on-site.

For more details please feel free to email