Role: Senior Regulatory Executive (Pharma)
Salary: Highly Competitive
Russell Taylor Group has a fantastic opportunity for a Regulatory Affairs Expert to join a Pharmaceutical manufacturing company based Wembley area. You will have a solid history of working within a pharmaceutical company and a solid background in Regulatory Affairs and the MHRA.
- 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
- 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 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