Principal Regulatory Consultant
Hyper Recruitment Solutions are currently looking for a Principal Regulatory Consultant to join a leading life sciences company based in the Cambridge... View Job
Regulatory Affairs Officer
Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Officer to join a leading biological pharmaceutical company based in the We... View Job
Regulatory Officer - Contract
Hyper Recruitment Solutions are currently looking for a Regulatory Officer to join a leading pharmaceutical company based in the Berkshire area. As th... View Job
Hyper Recruitment Solutions are currently looking for a Head of Regulatory Affairs to join a leading advanced therapies company based in the London area. As the Head of Regulatory Affairs you will lead environmental shaping activities and take overall regulatory responsibility for every programme sponsored by the company and for those programmes where the company has delegated regulatory responsibility.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Head of Regulatory Affairs will be varied however the key duties and responsibilities are as follows:
1. You will lead strategic regulatory influencing activity on behalf of the company with the goal of improving the regulatory environment for the development of cell and gene therapies in the UK.
2. As the Head of Regulatory Affairs you will lead the determination and implementation of optimal regulatory strategies for each programme in agreement with the DRA, CCO and key stakeholders.
3. You will lead compilation and submission of all regulatory contributions, ensuring that they are delivered to agreed time, cost and quality standards.
4. As the Head of Regulatory Affairs you will maintain up to date knowledge of development in regulations, CMC and GMP requirements for ATMPs.
To be successful in your application to this exciting opportunity as the Head of Regulatory Affairs we are looking to identify the following on your profile and past history:
1.Relevant life science degree, a higher degree would be an advantage.
2.Minimum 10 years' plus proven experience in an appropriate regulatory role, including previous leadership roles.
3.Extensive knowledge of EU, UK and FDA regulatory environments and experience in leading regulatory strategies for Advanced Therapy Medicinal Products including orphan indications.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant 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 scientists supporting science. We look forward to helping you with your next career moves.