Job Reference: J5632014
Updated On: 14/08/2019
Status: Under Offer
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Role OverviewWe are currently looking for a Director of Regulatory Affairs to join a leading Biopharmaceutical company based in the Wiltshire area. As the Director of Regulatory Affairs you will be responsible for working alongside the companies Managing Director to be the regulatory expert and lead, manage and direct all aspects of the companies regulatory strategy. This is an executive level appointment and it is expected you will be commercially aware of the bioprocess industry, advising on the best path of growth for the business and future commercialisation options.
Key Duties and ResponsibilitiesYour duties as the Director of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
1. Manage and maintain regulatory licences and approvals relating to manufacture, testing and distribution of medicinal products. Be the companies expert point of contact for regulatory authorities, customers, UK Government Departments on regulatory affairs
2. Develop and add to the current Regulatory Team to ensure the business can deliver on all strategic plans and ensure you respond to all matters related to the relevant regulatory authority.
3. As the Director of Regulatory Affairs you will be an executive in the company you will contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing regulatory focussed analysis and guidance on all activities, plans, targets and business drivers. This will involve presenting at company board meetings.
4. As part of your executive role you will co-ordinate commercial negotiations with customers in order to achieve project objectives, secure optimal cost recovery and protect intellectual property in accordance with company goals.
Role RequirementsTo be successful in your application to this exciting opportunity as the Director of Regulatory Affairs we are looking to identify the following on your profile and history:
1. Relevant degree (PhD preferable but not essential) in a life sciences discipline (i.e. Biochemistry, Chemistry, Pharmaceutical Management, Biological Sciences etc) with proven experience in leading a team to set and deliver the EU regulatory strategy related to biopharmaceutical product.
2. Proven industry experience operating at an executive level within a Biopharmaceutical business, pharmaceutical licensing procedures and pharmacovigilance reporting in the UK, EU and USA. You would also have a working knowledge of IMP licensing and clinical trial management.
3. A working knowledge and practical experience with UK/EU legislation associated with manufacture of pharmaceuticals and FDA 21CFR 210 & 211 is expected.
Key Words: Director of Regulatory Affairs / Regulatory Leadership / Biopharmaceutical / GMP / EU Regulatory Affairs / Executive Appointment / Senior Leadership Team /
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
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