Regulatory Affairs Consulting - the role can be at Project Manager, Senior Manager/Manager or Senior Associate Level. Salary range £50,000-£80,000pa plus package.

Hybrid working is permitted for this position.

Good all-round Regulatory experience is essential, the candidate cam come from a Clinical/Development, Registrations or Life-cycle management background. Equally, the candidate can come from a background in Pharma, Generics or OTC Products. Client-facing skills are welcomed but not essential.

This Consultancy provides high quality services to the Pharmaceutical Industry hence there is a certain amount of overseeing Consultancy projects. Clinical/Development through to Registrations/MAA's and Product Life-cycle management. The geographic scope of this role is Pan-European some International territories. Good working knowledge of core Regulatory Affairs is essential with working knowledge of Publishing/Operations a bonus. This role reports to the Director of Regulatory Affairs.

Your responsibilities will include Project Leading 'hands-on' & Advising on European Regulatory Affairs. Ideally, you will have good working knowledge and experience of: Phases I to IV: Clinical/Development Regulatory Affairs; Registrations and Post approval: CTA's, IND's, IMPD's, IB's, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, CTD/Dossiers for MAA's (overseeing all Modules 1 to 5); National Submissions/MRP, DCP and Centralised Procedure. Post Marketing/Life-cycle Management - Type Ia, Ib and II Variations, Renewals and Line extensions; Labelling, PIL's and SmPC's. Scientific Advice meetings and PIP's. Orphan Drugs.

As long as the candidate has part thereof of the above skills this should be sufficient for this role.

With experience in Regulatory Affairs Strategy, you will have some working knowledge of Regulatory Intelligence. You will have experience in taking products through Early and Late Phase, through to successful Registrations and beyond. You will have experience across numerous Therapeutic Areas.

You will possess good commercial awareness, a good understanding of how the business works, and how Regulatory matters can impact on 'the bottom line.' You will have and an excellent eye for detail.

Candidates from a Consultancy, Pharma, Biopharma, or perhaps a CRO background, in all-round European Regulatory Affairs with 3-8 years' experience should be suitable for this position.

Excellent salary. Joining this highly successful Consultancy is a significant commercial opportunity. Desirable location West of London, but hybrid working offered.

If you are interested in this, or any other Regulatory Affairs roles, please contact Julian Turner, at Turner Regulatory Recruitment, on +44 203 695 9477/+44 7447 977 330, or by julian@turnerregulatory.com or apply by clicking Apply Now.