Director / Head of Regulatory Affairs

Key People Limited
60,000 - 80,000
07 Oct 2017
05 Nov 2017
Contract Type
Full Time
A rare opportunity has arisen for a Regulatory Affairs Director / Head of Regulatory to lead the UK & Ireland Affiliate team based within a Top 5 Generics company based in Hertfordshire. Within this role you will lead a team of four people, two Senior Officers and two Principle Officers, and oversee the integration of two teams. If you have a strong background in team leadership and extensive UK/IE Affiliate Regulatory Knowledge, this role will offer you the opportunity to develop a new team, build the culture of the team and be part of a regulatory department with growing product responsibilities.Main Responsibilities:- To lead, develop and manage the affiliate for a generic and branded portfolio.- To ensure that the Regulatory Function operates in line with regional regulatory objectives and working practices and supports the local commercial objectives.- Provide strategic and operational management of products and projects working with initiative and in a proactive fashion with consideration for commercial implications. - Accountable for the regulatory output from the affiliate team, with emphasis on quality and timeliness; and to be personally responsible for a defined portfolio of products.- Ensure regulatory compliance of all UK, Ireland and Malta licences with relevant national and European regulatory requirements- Lead and participate in cross functional teams to ensure that business and regulatory objectives are met.- Develop working practices within the affiliate to ensure both compliance and statutory compliance is met. - Maintain an awareness of the changing regulatory environment for and ensure that the impact is fully assessed within the business. - Represent the affiliate at appropriate meetings with key stakeholders, both external and internal, including BGMA and ABPI.Required Experience:- TOPRA membership- Ability to navigate sensitive issues, provide solutions and work independently- Enthusiastic professional who can act with speed and confidence, ability to consider the needs of the team and focussing on getting the collective result.- Desire to grow and develop with the company, to contribute to the success of the company. - Minimum BSc in Pharmacy/Life sciences or related area.- Previous experience of managing a team essential- High degree of competence in the broader aspects of regulatory affairs in both branded and generic areas essential- Experience of working in an affiliate environment desirable.- Highly developed communication and presentation skills- Highly developed project management skills- Self-starter and highly motivatedFor further details, please contact Tim Barratt at Key People on +44(0)1727 817 626 or email