Our client is an organisation who are committed to providing a continuous and competitive supply of high quality plasma-derived products to health professionals throughout the growing global market. Over the last 50 years they have gained a considerable worldwide reputation for their life-saving products. Currently supplying products to the UK and over 45 international markets. With extensive research, development, manufacturing and commercial operations based out of the dedicated site in Elstree, Hertfordshire, they are looking to expand their product base and international scope.
The Head of Regulatory Affairs will report to the Technical Director and will have overall responsibility for regulatory affairs and compliance across the organisation's full product range. The position will manage an established regulatory team, who have responsibility for preparation and timely submission of all regulatory applications and control regulatory licences, the EU Plasma Master file, orphan products and regulatory aspects of new product development. As well as having a strategic and management role, this position will personally work on development and licensing issues.
For this role you will have successfully managed a team to achieve their goals and have a track record of developing the individuals in your team. As the position will manage a team of 4-5people, a non-hierarchical approach and the ability to work with individuals across a matrix organisation is essential. This diverse role will require the ability to prioritise multiple responsibilities and achieve commercial success for the organisation. The Head of Regulatory Affairs will be the main contact with European regulatory authorities and therefore it is essential you have first hand experience of regulatory interactions. Previous experience of working with biologics is also desirable but not essential.
How to apply for the Head of Regulatory Affairs role:
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Alternatively, for a confidential discussion concerning the Head of Regulatory Affairs opportunity you can telephone Amber Burns on +44 (0)1707 259333. Please be sure to quote 10209 in all correspondence relating to this role.
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