Linkfield Life Sciences are currently partnering with a small Pharmaceutical company who are looking to hire their first internal, permanent Regulatory Affairs member of staff. Currently all Regulatory Affairs activities are undertaken by external consultancies. This position will be responsible for managing external Regulatory Affairs partnerships that are already in places along with developing the internal Regulatory Affairs function. All activities will be based around UK and Ireland regulations.
- Ensuring appropriate license compliance for all company products. Ensure that the company's products comply with the regulations of the MHRA and HPRA.Processing and clear communication of regulatory approvals to internal and external stakeholders.
- Coordinate and use the services of contract regulatory affairs organisations as required.
- Preparation and submission of the MA variation and renewal applications.
- Preparation and submission change of ownership applications.
- Keeping up to date with relevant European regulatory legislation and guidelines.
- Ensure that registration dossiers are maintained current relative to other source information (eg, EDQM Certification, component suppliers).
- Collecting, collating and evaluating scientific data in support of product registrations.
- Provision of regulatory support for strategic commercial opportunities and technical projects.
- Developing and writing clear arguments and explanations for new product licences and licence renewals.
- Monitoring and setting timelines for licence variations and renewals.
- Maintaining company licences
- Maintain regulatory dossier and submission archives.
For further information please reach out to Natalie Hopkins via email@example.com or call 0207 183 5059
- A degree level qualification, ideally in the life sciences.
- Relevant experience working in regulatory affairs
- Knowledge of oral and parenteral dose-form manufacture and testing.
- An awareness of the European legislation governing the approval of products.