This is a challenging and stimulating organisation where the performance of the individual can really make a big difference to the companys success, and help move the company towards the next stage of their global ambition plans.
Accountabilities/Responsibilities:
-Responsible for contributing to the definition and successful delivery of the Regulatory strategy.
-Provide senior level guidance, influence and leadership through expert knowledge and credibility to internal and external customers.
-Effective management of the regulatory team ensuring the provision of high quality regulatory information and the compliance for all aspects of the company core business.
-Providing leadership and hands-on management for the team to enhance organisational regulatory competencies.
-To ensure appropriate development and mentoring of the regulatory team to encourage continuous improvement.
-To make the team and the company aware of UK and European market regulatory developments and opportunities that can be leveraged to the advantage of the company.
-Establish strong relationships with the regulatory bodies in the key strategic markets (France, Germany, USA, UK and Ireland).
-To provide a professional and high standard of support to new business proposals, propositions and customer events, attending and presenting as appropriate.
-Play a pivotal role in supporting, developing and implementing successful patient access programmes for our pharmaceutical markets.
-Support the Head of Regulatory Affairs and QA to develop and implement the strategic plan and budget.
-Ensure that company relationships, both tactical and strategic, with regulatory authorities are maintained and built upon to strengthen the company market leader position.
-Deputise for the Head of Regulatory Affairs as appropriate.
Essential Skills & Capabilities:
-Proven success of effectively managing a team, within an international context, to deliver against targets.
-Demonstrated understanding of European Regulatory and FDA requirements, with particular focus on the USA, France, Germany, UK and Ireland.
- Proven effective people management and team development abilities - coaching and mentoring.
-Proven excellence record in regulatory compliance and affairs.
-High level of senior regulatory expertise gained within a Pharmaceutical sector within an international context.
-Strategic thinker, translating and implementing strategy into tactical plans and actions.
-Proven ability of successfully delivering against targets within set parameters.


- regulatory affairs, drug development, licenses

- Surrey