Syrimed is one of the leading UK Pharmaceutical Companies specialising in the development, licensing, manufacture and marketing of liquid medicines. Syrimed is also a leading manufacturer and supplier of unlicensed medicines (also called specials) to community pharmacies, hospitals and wholesalers.
We are looking for an experienced Senior Regulatory Affairs Officer with experience in pre and post marketing who has not only UK/EU experience but has had exposure to the global markets working within other worldwide markets.
Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications.
Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national) and ensure timely submission of applications
Assist in the preparation and review of responses to requests for further information from regulatory authorities
Prepare or review of national submission packages after the close of procedures
Liaise with regulatory authorities when required
Maintaining the product life cycle once the licence is approved.
Responsible for the product approval package review and maintenance.
Review of product information before product launch.
Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards.
To support the Regulatory Manager with SOPs, Change controls and review of internal processes.
Keeping up-to-date with the current regulations/ guidelines and share the knowledge with the team.
Collaborate with internal departments for resolving any regulatory discrepancies.
Creating and monitoring internal quality and non-quality changes through change control system.
Proactively troubleshooting technical/quality issues relating to product preparations and submissions.
To liaise with CROs to ensure clinical trials are conducted in accordance with the regulatory requirements.
Liaise with contract manufacturers when required
Providing regulatory support to the other departments
Follow up with regulatory authorities on submissions and regulatory issues.
Training of junior members of the Regulatory Department
Involvement in review of third party dossiers when required
Established during 2004 in Ruislip, West London; Syrimed with the experience from the development and manufacture of unlicensed medicines started in 2014 to develop and obtain marketing authorisations for its own unlicensed liquid medicines. In August 2018, Syrimed held over 80 marketing authorisations for liquid medicines within the UK and other EU countries.
As a leading supplier of unlicensed medicines which are manufactured to meet the needs of patients which cannot be met with licensed medicines, Thame manufactures and supplies around 5000 formulations of unlicensed medicines.Our products are available for:
- Community Pharmacy
- Hospital Pharmacy
- Pharmaceutical Wholesalers
- Dossier Preparation
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