Senior Manager Regulatory Affairs / Regulatory Strategy, Development & MAA’s / Top Biotech / Flexibl

Location
Central London/Flexible
Salary
Competitive
Posted
14 Jun 2021
Closes
14 Jul 2021
Ref
cG9tqart6Eif
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Manager Regulatory Affairs / Regulatory Strategy, Development & MAA's / Top Biotech / Flexible Working

New Drug Applications/MAA's across European markets. Top Biopharma in Central London!!

Superb organisation - a top employer with outstanding products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Desirable Central London location with some flexible working.

Candidates from a Biotech, Biopharma or Pharma background, in European Regulatory Affairs Development & Strategy and Project Management/Leadership with 5 year's+ solid experience, should be suitable for this position. General Biologic experience is required and Gene or Cell Therapy/Advanced Therapy experience desirable. Rare Diseases & Orphan Drugs.

Regulatory Strategy and 'Hands-on', Project Managing across Europe. Are you a Senior Regulatory Project Manager/Manager with 5-10 years' experience, adept in European Regulatory Strategy and 'hands-on' Regulatory Development activity? If so, this is the opportunity you have been waiting for.

This Senior Regulatory Manager role is for a fast-growing and highly successful Biopharma with a portfolio of 'cutting-edge' products; this role focus primarily on a Gene Therapy Product in early development, and the role is based in a desirable area of Central London (flexible working). The role is focused on a variety of Regulatory activity, including Strategy across Development and New Product Registrations.

Reporting to The Senior Director Regulatory Affairs, you will Project Lead, be Proactive & Advise on European Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IMPD's, IB's, Protocols, up-dates/amendments, End of Trial Notifications, and other Regulatory Development activity; Scientific Advice meetings, PIP's & Orphan Drugs. CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing with Affiliates. Ideally, you will have experience of taking Products from Early & Late Phase, through to successful New Registration.

You will collaborate closely with all other key Global Regulatory Affairs stakeholders, in the USA and elsewhere, including other Global Regulatory Leads, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, in order to ensure that all aspects of the Regional Strategy is observed and implemented.

You will be required to interface with Commercial Teams and will operate as the primary interface with Affiliates across the EU. You will possess good commercial awareness and an excellent eye for detail.

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 1582 290 636; +44 7447 977 330, or julian@turnerregulatory.com, or submit an application by clicking Apply Now.

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