Senior Manager CTA/Clinical Regulatory Group Hub / Top Biopharma / New Unit
- Company
- Turner Regulatory
- Location
- Cambridge/Hybrid working, UK
- Salary
- Competitive
- Posted
- 20 Sep 2022
- Closes
- 18 Oct 2022
- Ref
- MItscwtQMKb5
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
New Unit
Senior Manager CTA Regulatory Group - Hub
Senior Manager Regulatory Affairs, CTA's & Clinical Development, Phases I to III - Subject Matter Expert (SME). Clinical/CTA Regulatory, 'hands-on' and Project Leading in European and International Markets - Biologics and Pharma Products.
This is a new Unit being established specifically for this purpose - this role will Manage and Lead projects.
This is a hands-on role, and less strategic - current 'hands-on' CTA/Clinical activity is essential for this role.
Hybrid working is possible for this position. Cambridge location.
Good all-round CTA Submission & Clinical Regulatory experience is essential, particularly - CTA's; experience in Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP's/Waivers is beneficial.
Full Clinical/Regulatory Pipeline exposure is required from initial CTA's (first-in-man) through to End of Trial Notifications. The geographic scope of this role is Pan-European & International territories. Good working knowledge of Biologics is ideal along with Pharma Products. This role reports to the Director.
Your responsibilities will include Project Leading & Advising on European & International Clinical Regulatory Affairs Strategy and Tactics (less), and Implementation (focus). You will have good working knowledge and experience of: Phases I to IV: Clinical/Development Regulatory Affairs: CTA's, IND's, IMPD's, IB's, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, Scientific Advice meetings and PIP's. Orphan Drugs.
Ideally 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 CRO, Biopharma or Pharma background, in all-round European & International Clinical Regulatory Affairs with over 7 years' experience and team mentoring skills should be suitable for this position.
Excellent salary package - £circa £75,000-£80,000 basic, 16% bonus, £7,900pa car allowance, generous RSU's/LTI's and other leading benefits. Joining this extraordinarily successful Biopharma is a significant commercial opportunity. Cambridge location with 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 +44 203 695 9477/+44 7447 977 330, or by julian@turnerregulatory.com or submit an application by clicking Apply Now.
Senior Manager CTA Regulatory Group - Hub
Senior Manager Regulatory Affairs, CTA's & Clinical Development, Phases I to III - Subject Matter Expert (SME). Clinical/CTA Regulatory, 'hands-on' and Project Leading in European and International Markets - Biologics and Pharma Products.
This is a new Unit being established specifically for this purpose - this role will Manage and Lead projects.
This is a hands-on role, and less strategic - current 'hands-on' CTA/Clinical activity is essential for this role.
Hybrid working is possible for this position. Cambridge location.
Good all-round CTA Submission & Clinical Regulatory experience is essential, particularly - CTA's; experience in Scientific Advice meetings with the Regulatory Authorities, Orphan Drugs/Rare Diseases and PIP's/Waivers is beneficial.
Full Clinical/Regulatory Pipeline exposure is required from initial CTA's (first-in-man) through to End of Trial Notifications. The geographic scope of this role is Pan-European & International territories. Good working knowledge of Biologics is ideal along with Pharma Products. This role reports to the Director.
Your responsibilities will include Project Leading & Advising on European & International Clinical Regulatory Affairs Strategy and Tactics (less), and Implementation (focus). You will have good working knowledge and experience of: Phases I to IV: Clinical/Development Regulatory Affairs: CTA's, IND's, IMPD's, IB's, Protocols, updates/amendments and End of Trial Notifications/other Development Regulatory activity, Scientific Advice meetings and PIP's. Orphan Drugs.
Ideally 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 CRO, Biopharma or Pharma background, in all-round European & International Clinical Regulatory Affairs with over 7 years' experience and team mentoring skills should be suitable for this position.
Excellent salary package - £circa £75,000-£80,000 basic, 16% bonus, £7,900pa car allowance, generous RSU's/LTI's and other leading benefits. Joining this extraordinarily successful Biopharma is a significant commercial opportunity. Cambridge location with 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 +44 203 695 9477/+44 7447 977 330, or by julian@turnerregulatory.com or submit an application by clicking Apply Now.