Regulatory Affairs Manager

Proclinical is seeking a Regulatory Affairs Manger to be based in London on a permanent basis. The Regulatory Affairs Managers at Cell and Gene Therapy Catapult act as a regulatory representative for company programmes. To implement optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs, Chief Clinical Officer (CCO) and key stakeholders. Compile and submit regulatory submissions, ensuring that they are delivered to agreed time, cost and quality standards. To support the development programmes in place in the company, providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements.

Job Responsibilties:

• With the Head of Regulatory Affairs, develop an agreed CMC and regulatory strategy and implementation plan for each programme.
• Prepare regulatory documents (briefing documents, GMO submissions, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards.
• To liaise closely with relevant departments of the company and external collaborators to ensure proposed developments (manufacturing and analytical) are fit for purpose and suitably planned whilst ensuring the development programme will meet regulatory and quality requirements.
• Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals.
• Maintain up to date knowledge of development in regulations, CMC and GMP requirements for cell and gene therapy products.
• Develop and maintain constructive working relationships with regulatory agency and health authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management.

Skills and Requirements:

• Approximately 3-5 years' or more regulatory affairs experience, ideally with 1-2 years in a cell and/or gene therapy environment or, at a minimum, with some experience in the regulation of biologic or biotech products.
• Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues including areas of biotechnology, biological therapies and preferably, cell and gene therapy.
• Ability to lead the quality and regulatory aspects of the development strategy for assigned company Programmes.
• Demonstrable regulatory leadership of IND and CTA processes as well as experience of scientific advice meetings with Regulatory Authorities an advantage.
• Proven examples of working independently in the drafting and delivery of high quality regulatory documents.
• Proven ability to consistently deliver to time, cost and quality standards.
• Proven ability to engage constructively with colleagues at all levels across difference departments to deliver objectives.
• Experience of registration of cell and gene therapies for clinical trial throughout the EU.
• Experience of EU centralised procedures such as ATMP classification, paediatric investigational plans and orphan drug applications.
• Knowledge of US, Japanese, Canadian or Chinese regulatory frameworks.
• Working knowledge of EU GMP and tissues and cells legislation.
• Experience of regulatory components of device development and registration an advantage.
• Experience in playing a role in early phase research and development programmes with a view to inclusion in regulatory submissions.
• Higher degree or at a minimum graduate in a life science subject.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alex Czuprynski on +44 203 8692 328 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.