Senior Director, Regulatory CMC / Top Biopharma / Rare Diseases / Strategy / Central London
- Employer
- Turner Regulatory
- Location
- London (Central), London (Greater) (GB)
- Salary
- A significant salary package is offered
- Start date
- 19 Apr 2019
- Closing date
- 19 May 2019
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- Discipline
- Regulatory Affairs, CMC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
Sensational Senior Regulatory CMC role; this is a rare opportunity to join a fast-growing and dynamic Biopharma in a great location in Central London; superb role and a career-making challenge. Development in Phases I to III, Registrations and Post marketing activity. General Biologics and Pharmaceutical experience highly desirable. Rare Disease Products/Orphan Drugs. Europe and Switzerland focus. Matrix-management environment. High-level Project Leading in addition to Line management of a small team – this role is a combination of Strategy, Development, ‘hands-on’ and people management.
This is a superb Regulatory CMC opportunity with significant financial possibilities. Experience in Biologics is desirable but not necessarily essential for this role. High-Level Project Leadership skills are vital, along with a background of working knowledge and experience within Regulatory Affairs Strategy, Tactics & Implementation, throughout the Regulatory pipeline. This individual will be responsible for the Regulatory Strategy of a number key products hence this is a very important hire. Geographical remit: Europe/Switzerland – knowledge of USA/FDA would be beneficial.
Reporting to the VP of Regulatory Affairs, this position has 7 reports in Europe within Regulatory Affairs. The candidate will possess an excellent understanding of 'how the industry works', is commercially astute, and have a good perception of how Regulatory CMC issues can impact on profitability.
There are a number of existing products in the pipeline hence the candidate’s responsibilities will encompass taking the assigned products successfully through Late Phases through to successful BLA’s/MAA’s.
The candidate will have particular expertise in Regulatory Strategy, Tactics and Implementation and have a deep 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 Clinical and Development Regulatory Affairs in Phases I to IV.
Although there is a small team to manage, 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 – in conjunction with the management of CRO’s. CTD/Dossiers for MAA's (particularly Modules 3 and 2.3); National Submissions/MRP, DCP, and particularly Centralised Procedure; Regulatory Strategy, Tactics and Implementation; Regulatory Intelligence, Scientific Advice meetings with the EMA. PIP's.
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 substantial Regulatory Affairs background within Biologics or Pharmaceutical of at least 10+ years. The candidate will demonstrate superb management and Project Leading skills along with mentoring of staff and the ability to develop and expand a team when necessary.
This position is based Central London, and requires travel as can be expected with a role of this seniority.
A significant salary package is on offer for the right candidate, this will include a superb basic, LTI’s, 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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- 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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