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Senior Regulatory Affairs Manager CMC / ADTHER / Strategy & Development

Employer
Turner Regulatory
Location
London/Flexible, UK
Salary
Competitive
Start date
29 Sep 2021
Closing date
29 Oct 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Manager Regulatory CMC - ATMP's and Biologics Regulatory Strategy, Regulatory Development, New Drug Applications/MAA's in the UK, and European markets. Based in Central London with flexible working.

Superb and unique 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. ATMP working knowledge is a preference.

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

Regulatory CMC Strategy and 'Hands-on', Project Managing across Europe. Are you a Regulatory Project Manager/Manager with approximately 5 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 organisation dealing with 'cutting-edge' products; this role focuses primarily on a Cell & Gene Therapy Products in early development, and the role is based in a desirable area of Central London (flexible working). The position is focused on a variety of Regulatory activity, including Strategy and Development leading to New Product Registrations.

Supporting The Head of Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK & European Regulatory CMC. Technically, you will have good working knowledge and experience of: Development and New Registrations: CTA's, IND'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.

You will be adept in Regulatory CMC Strategy & Tactics and have good experience in dealing with Clients. 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 Clients, to ensure that all aspects of the Regulatory Development Strategy are observed and implemented.

You may be required to interface with Commercial Teams and will operate as the primary interface with 3 rd Parties. 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.

Company

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Brief Company Description; 

Turner Regulatory Recruitment is headed by Julian Turner, whose knowledge of Regulatory Affairs Recruitment is significant, and connections with talented candidates in this area unsurpassed.

Julian Turner started his regulatory recruitment career in 2005, since when Julian and his team have created an outstanding database of candidates and other contacts who are always happy to take our calls.

Our candidates willingly engage with us because we have taken the time to get to know them and to understand their plans and their career ambitions. Indeed, it is quite likely we placed them in one of their roles over the past 15 years.

We work closely with our clients’ regulatory line/senior management, HR and talent acquisition/internal tecruitment teams. When they have a Regulatory Affairs vacancy, they rest assured knowing we will put forward on average ten or more exceptional candidates.

We are often called in where other recruiters have failed and are able to fill long-standing vacancies quickly and effectively.

We are proud to work with clients such as Roche, Norgine, BioMarin, Vertex, Shire, ReNeuron, Seqirus/CSL and numerous other organisations, successfully placing candidates in permanent and contract roles within Regulatory Affairs.

If you have a Regulatory Affairs vacancy and would like the opportunity to select from a pool of excellent candidates, please contact Julian and the team at Turner Regulatory Recruitment.

 

 

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Company info
Website
Mini-site
Turner Regulatory
Telephone
0203 695 9477
Location
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
United Kingdom

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