Remote working is offered 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 & Protocols. New filings: MAA's and BLA's.
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 Senior Consultant Regulatory Affairs will be responsible for Project Managing activities.
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 and BLA's (overseeing all Modules 1 to 5); 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. 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 7 years' experice should be suitable for this position.
Excellent salary package. £60,000-£90,000 basic depending on experience plus bonus and benefits.
Joining this highly successful Consultancy is a significant commercial opportunity. Desirable location North of London, but flexible working offered.
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