Senior Regulatory Executive
Amy Lloyd is recruiting for a Senior Regulatory Executive to join a rapidly expanding pharmaceutical company focused on the development & manufacture of high-quality and effective drugs for worldwide healthcare market at their site based in London on a permanent basis.
- 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.
- 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.
- 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.
- Good knowledge of UK 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.
- Oncology is desirable.
For more information or to apply for this position, please contact Amy Lloyd on 01438 842979 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47381 in all correspondence.