An independent biotechnology company based in London is seeking to recruit a Senior Regulatory Affairs Manager. The organisation is dedicated to advancing the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and full-scale commercialisation. This is a fabulous opportunity to work with a team that that offers leading-edge capability, technology, and innovation to enable companies to take products into clinical trials and commercialisation.
The Senior Regulatory Affairs (SRA) Manager will act as a regulatory representative for the company, providing operational management to the Regulatory Group and supporting the Head of Regulatory Affairs. They will focus on bolstering the clinical trial and manufacturing initiatives at the company, providing strong expertise in clinical trial submissions, CMC, and GMP requirements of product and process development for the EU and US markets.
Job Responsibilities:
- Ensuring
- Devising and implementing optimal regulatory strategies for each programme in agreement with the Head of Regulatory Affairs.
- Supporting the development programmes in place of company, providing expert advice to ensure the programmes are developed in a way which meets regulatory and quality requirements.
- Ensuring programmes meet required quality standards in accordance with all relevant regulations and the company quality management system.
- Compiling and submitting regulatory submissions, ensuring that they are delivered to agreed time, cost, and quality standards.
- Liaising closely with relevant company departments 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.
- Developing an agreed regulatory and strategy implementation plan for each programme in collaboration with the Head of Regulatory Affairs.
- Maintaining up to date knowledge of development in regulations, CMC, and GMP requirements for ATMPs.
- Authoring and compiling regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost, and quality standards.
- Ensuring appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals.
- Developing and maintaining constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management.
- Managing more junior members of the team, including the delegation of key activities
Skills and Requirements:
- Graduate in a life science subject as a minimum, post graduate degree desirable.
- Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred.
- Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products, including orphan indications.
- Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues, including advanced therapies.
- Proven examples of delivery of high-quality regulatory documents for advanced therapies, working independently.
- Demonstrable regulatory leadership of IND and CTA processes as well as experience of scientific advice meetings with Regulatory Authorities.
- Experience of working within quality management systems with understanding of their importance and essential requirements.
- Experience of registration of cell and gene therapies for clinical trials throughout the EU.
- Experience in GMP, Blood and Tissues and Cell, and GMO Legislation.
- Experience of FDA and EU centralised procedures such as orphan drug, paediatric and licensing applications.
- Experience of development indicatives such as the EU PRIME and FDA breakthrough therapy programmes.
- Experience of regulatory components of device development and registration.
- Experience in playing a role in research and development programmes with a view to inclusion in regulatory submissions.
- Experience of registration of cell and gene therapies for clinical trials in the US and other markets.
- Experience in authoring of proposals for external collaborators and grant giving bodies.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Pieter Verbeelen at +44 203 854 2628 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.
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