BioGrad biobank
BioGrad biobank

Vacancy

Job Description

Quality and Regulatory Affairs Specialist
REF: BG-QRAS-11.01.24
SALARY:£35,000-£45,000 Depending on Experience
REPORTS TO: Laboratory Director
ROLE PURPOSE / SUMMARY: 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

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.

Person Specification

Competency Criteria

Qualifications, Training & Knowledge

Essential

Desirable

Experience

Essential

Desirable

Skills & Behaviours

Essential

Circumstances

Company Benefits

35 days Holiday per annum pro rata
Employee Assistance Programme
Benefits Available after 1 years’ Service.
House Loan Scheme –   down payment on new home
Enhanced Maternity and Paternity Package
Enhanced Sickness and Absence Pay
Enhanced holiday package after 5 years and 10 years’ service

Apply Now

If you are interested in this job position, please send your CV with a covering letter to recruitment@biograd.co.uk

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