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Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma

Employer
Turner Regulatory
Location
Cambridge/Hybrid working, UK
Salary
Competitive
Start date
20 Sep 2022
Closing date
19 Oct 2022

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

Job Details

Manager Regulatory CMC / ROW / Emerging Markets / Leading Biopharma

Exciting Regulatory CMC role: this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location with some Hybrid Working. New Registrations (new launches) and Post approval. Regulatory CMC - Modules 2.3 and 3 Authoring. ROW/Emerging Markets - LATAM, Africa, Middle East, Asia/Pacific; some European filings. All National Submissions.

This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Experience in Biologics is desirable but not necessarily essential for this role. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration.

The candidate will have expertise in Regulatory CMC Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in ROW/Emerging Markets. The candidate will possess good Regulatory CMC pipeline experience, but with specific strengths in New MAA's and Post approval - IMPD's and Module 3 Authoring, Variations, etc. All National Submissions.

The company operates more on a matrix-management model hence the candidate must be prepared to be 'hands-on' and be heavily involved in the day-to-day management of Projects. The candidate will need to have a substantial background in Regulatory Strategy, ideally: CTD/Dossiers for MAA's (Module 3 and 2.3 writing); National Submissions; Regulatory Intelligence exposure and Scientific Advice meetings would be beneficial.

The successful candidate will possess a solid Regulatory CMC background within Pharmaceutical or Biologics or of at least 5+ years. The candidate will demonstrate solid Project Management skills.

This position is based in Cambridge, and may require some travel, as necessary. Hybrid working is permitted.

A generous salary package is on offer for the right candidate, this will include a superb basic, excellent bonus and numerous other 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 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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