Senior Regulatory Executive, Pharmaceutical **PRE & POST APPROVAL SUBMISSIONS **
Location: Wembley (some remote days could be arranged/ agreed)
Salary: Up to £54,000 DOE
Additional: Company bonus scheme, Healthcare Plan, Life Assurance, Pension, Parking onsite
Our Client, a leading Pharmaceutical manufacturing and Pharmaceutical distributor are looking to recruit for an experience Senior Regulatory Executive (SRE) to work at their modern site near to Watford; the SRE will play a vital role in the preparation and submission of documentation, as well as management of the regulatory function/s.
Reporting to the RA Manager:
- Assisting in the preparation and review of dossiers for applications and ensure timely submission of the applications.
- Assisting in the preparation and review of dossiers for variation applications, renewals and other regulatory submissions (DCP, MR or national) and ensure the timely submission of applications
- Assisting in the preparation and review of response/s to requests for further information from regulatory authorities
- Preparing or reviewing of national submission packages after the close of procedures
- Liaising with regulatory authorities when required
- Maintaining the product life cycle once the licence is approved
- Responsible for the product approval package review and maintenance
- Reviewing of product information before the launch
- Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards
- Supporting 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.
- Collaborating with internal departments and resolving any regulatory discrepancies
- Creating and monitoring internal quality and non-quality changes through change control system/s
- Troubleshooting technical/quality issues relating to product preparations and submissions
- Liaising with CROs to ensure clinical trials are conducted in accordance with the regulatory requirements
- Liaising 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
- Will hold a Degree in a relevant - Life Sciences or related subject
- Experience in both pre & post submission experience (ESSENTIAL)
- Solid management experience in an RA role; within an Pharmaceutical - GMP setting
- Someone with experience dealing with EU, US, Canada and Middle East territories within RA
- Good knowledge of EU directives, ICH guidelines
- Strong leadership skills