Join one of the world’s most innovative Pharmaceutical companies and lead their Regulatory & Safety teams through Brexit and beyond.
Do you have strong Technical and People Leadership experience, including top class change management skills? Are you a Pharmaceutical professional with a background in Reg Affairs and / or Safety? Have you been following the news on Brexit? Do you see how it will bring both challenges and opportunities for international business processes?
If you can answer YES to all of these questions, then this could be the ideal career move for you. A global Pharmaceutical company near Gatwick Airport has created a new vacancy for a Regulatory & Safety Manager, to take charge of a team of 8 people (all of whom have strong technical skills and knowledge) and guide them through the lead-up to Brexit and beyond. This is a permanent role which will suit someone with a strong life science education, a background in Regulatory Affairs and / or Safety / Pharmacovigilance, and proven technical management skills that have been gained through periods of change.
As a Regulatory and Safety Manager you will be responsible for leading a team of 8 Regulatory and Safety/PV professionals and you will report into the Clinical Medical and Regulatory Director for the UK. The crux of this role will revolve around managing the team through the impending change that Brexit will have upon the company and its international Regulatory and Pharmacovigilance processes. This will mean you need to be a real people person and hands-on manager who has preferably helped lead teams through periods of change before. This means that technically you have to be well established and have considerable expertise in a matrix structure of a large pharmaceutical organization.
You will be part of the CMR Management team and contribute to the growth and development of the UK organisation whilst contributing to the larger European Regulatory team. Your main responsibilities will include supporting product development programmes from early phase clinical trials through to the generation and maintenance of commercially viable product licenses for the organisation. You will need to liaise with business units in order to map business needs vs. planned changes to regulatory files, as well as managing the UK product safety systems/processes in order to meet legal requirements. You will also be required to manage the business area complaints processes in collaboration with the team and to Act as the Safety Responsible Person in the UK.
This is a varied, challenging role involving a range of cross-functional projects that involve internal and external stakeholders. The company has an incredible range of product pipelines and this position will give you exposure to a number of products at different stages of development, all of which will be affected one way or another by Brexit.
A market leading global Pharmaceutical organisation offering innovative and life-saving treatments for conditions that include diabetes. The Crawley site houses a number of office-based teams responsible for co-ordinating the company’s UK activities relating to Sales & Marketing, Medical Information and Clinical Research. The Crawley facility is easily accessible and offers a state-of-the-art office environment.
The Regulatory and Safety team is made up of 8 professionals and sits within the wider Clinical, Medical and Regulatory department (over 120 individuals). The increasing requirements both for products in development and inline licenses, prospect of Brexit and the all-time importance of pharmacovigilance has made this role so critical. If you enjoy leading a team through important changes and new challenges then our Regulatory & Safety manager role will be a good fit for you. This is a leadership role to develop and grow a team whilst working on an exciting pipeline.
In addition to a very competitive salary (around £65,000 but potentially flexible depending on the candidate), the company offers the following benefits package:
- Company car
- Annual bonus (based on a combination of personal and company performance)
- Private healthcare
- Life assurance
- Pension scheme
- Flexible benefits
- 27 days holiday
The successful candidate must have a life science education (degree or above), a very strong understanding of MHRA and EMA requirements, and a solid background in either Regulatory Affairs or Safety / Pharmacovigilance (ideally both). Crucially, you will need to have strong team leadership experience, including expertise in Change Management and helping teams through periods of change and uncertainty. Knowledge of a few therapy areas would be advantageous, ideally with a particular focus in Biopharmaceutical development or obesity investigations.
This is a permanent role