Skip to main content

This job has expired

Associate Director, Regulatory Strategy / Clinical/Development / Complex Submissions - MAA's & New I

Employer
Turner Regulatory
Location
Central London/Hybrid Working, UK
Salary
Competitive
Start date
25 Jul 2022
Closing date
24 Aug 2022

View more

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

Job Details

Associate Director, Regulatory Strategy

Regulatory Strategy, Clinical/Development and Complex Submissions - MAA's & New Indications across European Markets. Top Biopharma in Central London with hybrid working offered!!

Regulatory Strategy, Project Managing and Support across Europe. Are you a Senior Regulatory Project Manager/Manager, or already an Associate Director, adept in European Regulatory Strategy and 'hands-on' Regulatory Clinical/Development activity? If so, this is the opportunity you have been waiting for.

This Associate Director, Regulatory Strategy role is for a fast-growing and highly successful Biopharma with a portfolio of 'cutting-edge' products both in Development and Post approval.

Liaising with the Global Regulatory Lead (GRL), you will Project Lead & Advise on European Regulatory Affairs Strategy!! Ideally, you will have good working knowledge and experience of: Clinical/Development, New Registrations both Pre- and Post-approval: CTA's and other Clinical/Development activity; CTD/Dossiers for MAA's; National Submissions/MRP, DCP and particularly Centralised Procedure.

CTA's, Scientific Advice and Pre-Submission meetings, Orphan Drugs (ODD's) and PIP's.

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

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

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

Candidates from a Biopharma or perhaps a Pharma background, in European Regulatory Affairs Strategy and Development with 7+ year's+ solid experience, should be suitable for this position.

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, including good basic, bonus, car allowance, LTI's/RSU's and other leading benefits.

Desirable Central London location which is also convenient for those who live West of London although hybrid working is offered. Some Travel may be required in this role.

If you are interested in this, or any other Regulatory Affairs roles, please get in touch with Julian Turner, at Turner Regulatory Recruitment, on the number provided, or by email, or submit an application by clicking Apply Now.

Company

Find out more about working for our company

Turner-Regulatory-Recruitment -hub-button

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.

 

 

 Follow us on LinkedIn...

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

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert