Description
Role: Regulatory Affairs ConsultantDuration: 3 months
Location: West London
Rate: £30 - £40p/h
The ideal candidate will be able to commence work by the end of May and have the following experience:
- Preparation and timely submission of key regulatory documents such as MA applications - National/MRP/DCP, variations / post marketing changes.
- Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
- Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations.
- Review and approval of Manufacturing, packaging documents, specifications and test procedures in accordance with registered dossier.
- Artwork/labeling approval
- Interfaces as needed with manufacturing, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system. Ideally the candidate will have some experience of production operations, and be able to review and approve blank manufacturing documents and compare them to the registered dossier.
- Assisting in the developing and maintenance of in-house regulatory systems and procedures.
- Participate in regulatory inspections, if required.
- Supporting Quality functions such as audit, vendor qualification and oversight, CAPA, OOS, change control
- Taking newly developed formulations from R and D, and prepare them for submission in both National and DCP procedures. Arranging the User Testing, and supporting risk management and SPS documents fromPharmacovigilence team
- Working closely with the Packaging Department
- Managing the Stability Cell and responsibility for all Protocols and SOPs on the site related to Quality
- Maintaining a product range of over 100 MAs
- Managing the filing of new pipeline of products coming from R and D
If this role is of interest and you would like to discuss it further then please don't hesitate to contact Peter Duvall on
To find out more about Real please visit www.realstaffing.com