Regulatory Affairs Manager
Oliver Care is recruiting for a Regulatory Affairs Manager to join a company in the area of Cell Therapy at their site based in London on a permanent basis.
The main purpose of the role will be to:
- Act as a regulatory representative by implementing optimal regulatory strategies for each programme in agreement with the Head of RA, CCO and key stakeholders, compiling and submitting all regulatory submissions ensuring they meet agreed time, cost and quality standards and ensure programmes meet require quality standards in accordance with all relevant regulations and the company quality management system.
- With the Head of RA develop an agreed regulatory strategy and implementation plan for each programme.
- Maintain up to date knowledge of development in regulations for cell based medicinal products and ATMPs.
Further responsibilities will include:
- Preparing regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports etc. to meet business needs and agreed time, cost and quality standards and ensure appropriate due diligence is carried out on all incoming propositions.
- Inputting into the design and implementation of an appropriate quality system for the company.
- Developing and maintaining constructive working relationships with Competent Authority and Health Authority contacts and contribute to strategies to influence regulators towards appropriate risk evaluation and management.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or above in a life sciences subject with experience in advanced therapy/cell based medicinal products and the proven ability to evaluate and implement efficient regulatory strategies and manage complex issues in the areas of biotechnology, biological therapies and preferably advanced therapies.
- Proven experience of delivering high quality regulatory documents to consistent time cost and quality standards and experience of working within quality management systems.
- Excellent interpersonal, organisational and communication skills with a strong focus on attention to detail.
This is an excellent opportunity to join a nationwide initiative in an exciting field of cutting edge technology dedicated to helping the delivery of life changing cell therapies.
For more information or to apply for this position, please contact Oliver Care on 01438 743047 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL30149 in all correspondence.