Principal Consultant Regulatory Affairs, Clinical Development -

Principal Consultant Regulatory Affairs, Clinical Development – Director Level. Regulatory Strategy, 'hands–on' and high–level Project Leading in European and US Markets – Biologics.

Remote working is possible for this position.

Top Consultancy in Home Counties North with remote working!! Rare and much–prized role!!

Good all–round Regulatory experience is essential, particularly Clinical/Development & Strategy – CTA's, Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP's/Waivers.

This Consultancy provides high quality services to the Biotech and Pharmaceutical Industries hence there is a certain amount of overseeing consultancy projects. Full Regulatory Pipeline exposure is required from Clinical/Development, through to Registrations and Post marketing. The geographic scope of this role is Pan–European & USA with some International territories. Good working knowledge of Biologics is ideal along with Pharma Products. This role reports to the Managing Director.

As Principal Consultant Regulatory Affairs will be responsible for mentoring and leading other Regulatory Staff.

Your responsibilities will include: Project Leading & Advising on European & USA Regulatory Affairs Strategy, Tactics, and Implementation. 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: Type Ia, Ib and II Variations and Renewals; Labelling, PIL's and SmPC's. PSUR's. Scientific Advice meetings and PIP's. Orphan Drugs.

Strong in Regulatory Affairs Strategy, Tactics, and Implementation, 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 Post marketing. 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 & USA Regulatory Affairs with over 10 years' experience and team mentoring skills should be suitable for this position.

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

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on / , or by or submit an application by clicking Apply Now.