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Associate Director, UK Regulatory Affairs / Biosimilars, Branded, Generics and OTC Products

Employer
Turner Regulatory
Location
Hertfordshire/Essex
Salary
Competitive
Start date
14 Apr 2021
Closing date
14 May 2021

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

Job Details

Associate Director, UK Regulatory Affairs!! Biosimilars, Branded, Generics & OTC Products. Manage the team and Project Lead. New MAA Submissions and filings focus.

Are you a UK Senior Regulatory Project Manager/Senior Manager with 8+ 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 leading Pharma/Generics employer with a variety of Products and very desirable to have on your CV. A very competitive salary package is on offer for the right candidate. Desirable North of London location with 1 to 2 days per week working from home.

Candidates from a Pharma or Generics background, in UK Regulatory Affairs, and Project Management/Leadership with approximately 8 year's+ solid experience, should be suitable for this position.

Close relations with the MHRA are desirable.

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

This Associate Director, Regulatory Affairs role is for a fast-growing and highly successful Pharma/Generics Company with a large portfolio of products. The role is focuses on a variety of Regulatory activity, including Strategy across New Product Registrations & Post approval. Biosimilars, Branded, Generics & OTC Products.

Reporting to The Director Regulatory Affairs, you will Project Lead, be Proactive & Advise on UK Regulatory Affairs. Technically, you will have good working knowledge and experience of: Development and New Registrations: 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. BROMI Applications. CMC knowledge. Exposure to PIP's and ODD's are ideal.

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

You will collaborate closely with all other key European & Global Regulatory Affairs stakeholders and Global 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.

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.

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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