Regulatory CMC Manager / Fast-growing Biopharma / Central London
- Employer
- Turner Regulatory
- Location
- London (Central), London (Greater)
- Salary
- £50,000-£65,000, great bonus, and leading benefits
- Start date
- 16 Sep 2019
- Closing date
- 16 Oct 2019
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- Discipline
- Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Manager Regulatory CMC. Exciting Regulatory CMC role; this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London. Regulatory CMC Development in Phase III leading to an MAA – Centralised Procedure. General Biologics and Pharmaceutical experience are required. Rare Disease Products/Orphan Drugs. Europe and Switzerland focus. Matrix-management environment. Project Managing – this role is a combination of Strategy, Development and ‘hands-on’. IMPD’s and Module 3 Authoring.
This is an excellent Regulatory CMC opportunity with significant possibilities for advancement within this exciting organisation. Experience in Biologics is essential for this role, as is Centralised Procedure. Project Management skills, along with a background and working knowledge of Regulatory Affairs Strategy, Tactics & Implementation, throughout Regulatory CMC Development and Registration. Geographical remit: Europe/Switzerland.
There are several existing products in the pipeline; however, the candidate’s responsibilities will encompass taking an assigned product successfully through Phase III through to a successful BLA/MAA. Scientific Advice meeting experience.
The candidate will have expertise in Regulatory Strategy, Tactics and Implementation and have a good understanding of Core Regulatory Affairs, particularly in Europe and Switzerland. The geographic scope of this role is Pan-European, within the context of Global Regulatory Affairs. The candidate will possess full Regulatory pipeline experience, but with specific strengths in Development Regulatory Affairs CMC in Phases II to IV - IMPD’s and Module 3 Authoring etc.
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 Development Regulatory, ideally: IMPD's, IB's, Protocols, up-dates/amendments and End of Trial Notifications. CTD/Dossiers for MAA's (particularly Module 3); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics and Implementation; Regulatory Intelligence, Scientific Advice meetings with the EMA.
A demonstrable working relationship with the major Regulatory Agencies and contacts within the EMA and other national Authorities would be an advantage in terms of company representation.
The successful candidate will possess a solid Regulatory CMC background within Biologics or Pharmaceutical of at least 6+ years. The candidate will demonstrate solid Project Management skills.
This position is based Central London, and may require some travel, as necessary. Some flexible 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
Find out more about working for our company
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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- Website
- http://www.turnerregulatory.com/
- Mini-site
- Turner Regulatory
- Telephone
- 0203 695 9477
- Location
-
71-75 Shelton Street
Covent Garden
London
WC2H 9JQ
United Kingdom
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