Regulatory Affairs Manager - Pharmaceutical
Our Client, a leading Pharmaceutical company based in Manchester are looking to recruit for an experienced RA Manager. Reporting to the Head of Quality, the RA Manager will manage the RA and Administrative functions.
- Co-ordinating all client liaison with respect to new MA or changes to existing MAs.
- Ensuring that changes to all site documents relating to client requests and information are reviewed and amended via Change Management as appropriate.
- Reviewing and approving client artwork for packaging components for compliance with the MA and known labelling legislation.
- Member of the site Change Management Review committee in relation to changes affecting client documents and systems.
- Liaise with clients in order to obtain Annual Product Quality Reviews and Stability Data and Technical Agreements in support of Qualified Person (QP) release on site.
- Assist with site Projects.
- Assist in regulatory/client inspections as required
- To support and co-ordinate the QA documentation team
- Responsible for document archiving and retrieval
- To assist with inspections by external auditors e.g. MHRA.
- To coach and mentor other staff in relation to regulatory requirements.
- To resolve regulatory/quality issues relevant to new product introduction, including outsourced manufacture, preparation of technical agreements, documentation, compliance and compatibility with client and site requirements.
- To liaise directly with client companies and regulatory bodies concerning regulatory/QA issues.
- Improve document issue and review throughput
- Will hold a Degree in a relevant/ Scientific Discipline
- Significant (ideally 5+ years) RA experience in a related Pharmaceutical setting
- To be registered with TOPRA would be an advantage
- Strong interpersonal - leadership skills
- Management skills - role holder has responsibility for coaching and mentoring other staff in relation to regulatory changes.