Quality and Regulatory Affairs Specialist
Description
The post holder will work with a team of scientists and other commercial positions to achieve GMP grade manufacturing authorisation for cell therapy products as well as other relevant regulatory certifications (e.g. HTA and AABB). They will also support the team by managing relevant quality management systems and/or leading on quality management activities
Reports to: Laboratory Director
REF: BG-QRAS-11.01.24
Role-specific responsibilities
1. Regulatory registration
- Preparing submissions of regulatory approval/certification (e.g. GMP, MHRA, HTA)
- Submitting license applications to authorities to strict deadlines
- Participating in discussions and conversations with regulatory bodies and government agencies
- Keeping up to date with the company’s product range
- Maintaining a deep understanding of new and existing regulations that may impact their organisation’s products and processes
- Setting and communicating timelines for licence approvals, variations and renewals
2. Quality Management
- Understanding of GMP and other relevant regulatory documentation for cell therapy products (e.g. HTA)
- Creating and updating documentation for regulatory certification
- Lead on external audits by regulatory bodies
- Participating in risk management activities for product ranges
3. Project Management
- Leading and managing routine and project based regulatory activities demanded for regulatory approvals such as stability testing, process validation and environmental monitoring
- Provide expert knowledge of facility and process design, management and maintenance that will enable and facilitate regulatory registration
- Evaluating raw materials, ingredients, and formulated materials to meet applicable regulations and support relevant data capture
- Manage own time independently under supervision of line manager.
4. General
- Liaise and work collaboratively with your team members.
- Attend team meetings and participate by providing new ideas and solutions as required
- Keep up to date with all regulatory knowledge and skills in line with current best practices, to ensure continuous professional development
- Communicate between the rest of your team and other departments to allow smooth operations.
Competency Criteria
Qualifications, Training & Knowledge
- Degree of Pharmacy or Scientific Degree
- Extensive knowledge of MHRA, HTA and AABB regulations/guidelines
- Knowledge of regulatory routes and challenges to market for cell and gene therapies within the UK, EMA and/or FDA regulated territories
- Knowledge of laboratory Health and Safety as it pertains to the area of cell and gene therapies
- Evidence of continuous professional development ideally in relation to cell and gene therapy regulations
Experience
- Working experience in a commercial cleanroom manufacturing environment to GMP standards ideally within the area of cellular therapeutics
- Proven expertise of successful regulatory submission for medical products on a European & UK Basis
- Proven experience of working in a laboratory and carrying out technical procedures
- Experience of interpreting legislation into an implementation plan
Skills & Behaviours
- Willingness and ability to work within the laboratory if required
- Ability to work independently, show initiative, problem solve and achieve agreed objectives to agreed timelines
- Understand the pressures and priorities within a commercial environment with a focus on quality and regulatory compliance
- Excellent interpersonal skills and at ease when communicating with regulatory authorities and other external agencies
- Enthusiastic and flexible approach to work.
- Proven success at meeting strategic goals. Ability to work under pressure while maintaining standards of service.
- Excellent communication skills with the ability to communicate and translate regulatory information clearly, orally, and in writing.
- Excellent planning, and organisational skills with the ability to prioritise tasks and meet deadlines.
- Reliable. Be able to stick to non-negotiable external deadlines.
- Attitude. Professional but friendly.
- Strong team player with excellent communication skills, work ethic and attention to detail
- Evidence of continuous professional development ideally in relation to cell and gene therapy regulations
Circumstances
- The post requires a flexible approach to working hours.
More Information
Contract
Salary
£35,000-£45,000 Depending on Experience
