UK Regulatory Affairs Manager

Manager, UK Regulatory Affairs!! Project Manage and Lead UK Submissions – Biologics and Pharma Products, but no prior Biotech product experience is required provided there is good UK Affiliate working knowledge. Strong Labelling experience an advantage; CMC and non/CMC combination. A great salary package offered to the right candidate.

Are you a UK Regulatory Project Manager or top-end Senior Associate with 3-5+ years’ experience, adept in UK Regulatory Strategy and ‘hands-on’ Regulatory activity? If so, this is the opportunity you have been waiting for!!

Superb organisation - a top Biopharma employer with ‘cutting-edge’ Products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Desirable Sussex location with flexible working arrangements.

Candidates from a Pharma, Biotech or Generics background, in UK Regulatory Affairs Development & Strategy and Project Management/Leadership with approximately 3-5+ year's+ solid experience, should be suitable for this position.

Close relations with the MHRA are desirable as is Pharma & Biopharma Product experience.

Regulatory Strategy and ‘Hands-on’, Project Managing in UK Affiliate Market. Operate within a matrix environment and multi-functional teams.

This Manager, Regulatory Affairs role is for a fast-growing and highly successful Biopharma with a portfolio of ‘cutting-edge’ products. The role is focuses on a variety of Regulatory activity, including Strategy across New Product Registrations & Post approval.

Reporting to The Head of Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: New Registrations and Life-cycle management: CTD/Dossiers for MAA's; National Submissions/MRP, DCP and Centralised Procedure. Post Marketing: Type Ia, Ib and II Variations, Renewals and Line Extensions; Labelling, PIL’s and SmPC’s. Sunset Clauses. BROMI Applications.

Past Scientific Advice meetings with the MHRA would be ideal.

You will be adept in Regulatory Strategy & Tactics and have good experience in dealing within a UK Affiliate. Ideally, you will have experience of taking Products from successful New Registration through to Post Marketing.

You will collaborate closely with all other Regulatory Affairs stakeholders and Regulatory Leads if required, Labelling, CMC, Regulatory Operations, other Regulatory Teams and Regulatory Affiliates, to ensure that all aspects of the Regional Strategy are observed and implemented.

You may be required to interface with Commercial Teams. You will possess good commercial awareness and an excellent eye for detail.

Desirable Sussex location with flexible working arrangements. An excellent salary package is offered, including great bonus, car allowance and leading benefits.

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 apply by clicking Apply Now.