My client, an expanding Clinical Research Organisation are currently seeking to recruit a Regulatory Affairs Manager to join their Regulatory team. This position plays a...
My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit a Regulatory Affairs Senior Manager. The role will be based at my client's offices in Central London.
The Regulatory Affairs Manager acts as a regulatory representative for programmes. This role has a focus on supporting the development programmes run by the Industrialisation Group and as such calls for expertise in quality (CMC) requirements of product and process development.
- To support the development programmes in place providing expert advice to ensure the programmes are developed in a way which meet regulatory and quality requirements.
- To implement optimal regulatory strategies for each programme in agreement with Senior Regulatory Affairs Managers, Head of Regulatory Affairs, COO and key stakeholders.
- Ensure programmes meet required quality standards in accordance with all relevant regulations and the quality management system.
- In addition, they will be required to compile and submit all regulatory submissions from time to time, ensuring that they are delivered to agreed time, cost and quality standards.
- To liaise closely with relevant departments of 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.
- With the Senior Regulatory Affairs Managers and Head of Regulatory Affairs, develop an agreed CMC and regulatory strategy and implementation plan for each programme.
- Maintain up to date knowledge of development in regulations, Quality (CMC) and GMP requirements for cell and gene therapy products.
- Prepare regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc) to meet business needs and agreed time, cost and quality standards.
- Ensure appropriate regulatory due diligence is carried out on all incoming propositions and external facing proposals.
- Develop and maintain constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management.
Skills and Experience required:
- Life sciences degree qualified
- Experienced in working within Regulatory Affairs within cell and gene therapy and / or other novel medicinal products.
- Proven ability to evaluate and implement efficient regulatory strategies and manage complex regulatory issues including areas of biological therapies and preferably, cell and gene therapy products with a particular focus on quality (CMC) development.
- Ability to lead the quality and regulatory aspects of the development strategy for all Programmes.
- Proven examples of delivery of high-quality regulatory documents including CTA/IND
- Expert in quality (CMC) requirements, with a strong understanding of product development processes.
- Experience of registration of cell and gene therapies for clinical trial throughout the EU, and US an advantage.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.