Regulatory Affairs Officer

Posted 21 October by SyriMed
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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.

The role of the Regulatory Affairs Officer will involve working in a busy team looking after the product life cycle with regard to all regulatory matters. You will be preparing, reviewing and submitting applications relating to MA applications and MA variations, and various other duties as listed below.

PRIMARY RESPONSIBILITIES

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.

SECONDARY RESPONSIBILITIES

 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

 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

 Deputise for Regulatory Affairs Manager in his/ her absence

ESSENTIAL

 Degree in life science subject with good knowledge of medicines and how they are used

 Well-developed regulatory experience in the pharmaceutical industry.

 Understanding of the drug development process.

 Knowledge of EU directives, ICH guidelines.

 Ability to prepare high quality regulatory dossiers

 Ability to communicate effectively with regulatory authorities and other departments.

 Ability to handle multiple tasks in a fast-paced and constantly changing environment

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

If this is of interest apply now to Geoff Flavell-Matts - Talent Acquisition Officer, for a chance to join a busy, growing pharmaceutical company and be part of its future continued success.

AGENCIES BY INVITATION ONLY

Required skills

  • Applications
  • Pharmaceutical
  • Product Life Cycle
  • Regulatory Affairs
  • Regulatory Submissions

Reference: 40838067

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