REMOTE WORKING – Head of Clinical Regulatory Affairs – Consultancy
Head of Clinical Regulatory Affairs - Consultancy
Lead the UK Clinical Regulatory Team
High-Level Project Leading
Client-facing skills
REMOTE WORKING – Head of Clinical Regulatory Affairs/Principal Consultant. Lead the UK Clinical Regulatory Team. Regulatory Strategy, ‘hands-on’ and high-level Project Leading in European and US Markets – Biologics. Client-facing skills.
Remote working is offered for this position.
Top Consultancy in Home Counties North with remote working!! Key role!!
Good all-round Regulatory experience is essential, particularly Clinical/Development & Strategy – CTA’s, Protocols, Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP’s/Waivers. 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 Head of Clinical you will be responsible for the UK Clinical Regulatory Staff.
Your responsibilities will include: Line management of the UK Clinical Regulatory Team, Project Leading & Advising on European & USA Regulatory Affairs Strategy, Tactics, and Implementation. You will have excellent 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 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 10-15 years’ experience and team leading skills should be suitable for this position.
Excellent salary package. £120,000-£140,000 basic depending on experience plus bonus and benefits.
Joining this highly successful Consultancy is a significant commercial opportunity. Desirable location North of London, but remote 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 +44 203 695 9477/+44 7447 977 330, or by julian@turnerregulatory.com or submit an application by clicking Apply Now.
Head of Clinical Regulatory Affairs - Consultancy
Lead the UK Clinical Regulatory Team
High-Level Project Leading
Client-facing skills
REMOTE WORKING – Head of Clinical Regulatory Affairs/Principal Consultant. Lead the UK Clinical Regulatory Team. Regulatory Strategy, ‘hands-on’ and high-level Project Leading in European and US Markets – Biologics. Client-facing skills.
Remote working is offered for this position.
Top Consultancy in Home Counties North with remote working!! Key role!!
Good all-round Regulatory experience is essential, particularly Clinical/Development & Strategy – CTA’s, Protocols, Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP’s/Waivers. 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 Head of Clinical you will be responsible for the UK Clinical Regulatory Staff.
Your responsibilities will include: Line management of the UK Clinical Regulatory Team, Project Leading & Advising on European & USA Regulatory Affairs Strategy, Tactics, and Implementation. You will have excellent 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 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 10-15 years’ experience and team leading skills should be suitable for this position.
Excellent salary package. £120,000-£140,000 basic depending on experience plus bonus and benefits.
Joining this highly successful Consultancy is a significant commercial opportunity. Desirable location North of London, but remote 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 +44 203 695 9477/+44 7447 977 330, or by julian@turnerregulatory.com or submit an application by clicking Apply Now.