Associate Director Regulatory Affairs, Clinical Development / Top
- Recruiter
- Turner Regulatory
- Location
-
Oxfordshire
South East EnglandUnited Kingdom
- Salary
- Competitive
- Posted
- 15 May 2022
- Closes
- 10 Jun 2022
- Job Title
- Associate Director
- Category
- Public Sector
- Contract Type
- Permanent
- Hours
- Full Time
Associate Director Regulatory Affairs, Clinical Development. Regulatory Strategy, 'hands–on' and high–level Project Leading in European and US Markets – Pharma & Biologics.
Hybrid working is possible for this position.
Top Consultancy in Home Counties West with remote working!! Rare and much–prized role!!
Good all–round Clinical/Development & Strategy – CTA's, IND's, IMPD's, IB's, Protocols, up–dates and amendments and End of Trial Notification; ideally, 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 advantageous, but with a particular focus on Clinical Development. 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 Associate Director Regulatory Affairs, you will be responsible for mentoring other junior 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; 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, CRO, Pharma or a Biopharma background, in European Clinical Regulatory with over 7 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 West of London, but hybrid 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.
Hybrid working is possible for this position.
Top Consultancy in Home Counties West with remote working!! Rare and much–prized role!!
Good all–round Clinical/Development & Strategy – CTA's, IND's, IMPD's, IB's, Protocols, up–dates and amendments and End of Trial Notification; ideally, 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 advantageous, but with a particular focus on Clinical Development. 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 Associate Director Regulatory Affairs, you will be responsible for mentoring other junior 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; 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, CRO, Pharma or a Biopharma background, in European Clinical Regulatory with over 7 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 West of London, but hybrid 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.