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Senior Regulatory Affairs Executive- Pharmaceutical

Vacancy Title: Senior Regulatory Affairs Executive- Pharmaceutical
Contract Type: Permanent
Location: Wembley, London
Industry:
Salary: Up to £0.00 per annum
REF: J905602_1592835110
Contact Name: Hannah Williams
Contact Email: Hannah.Williams@russell-taylor.co.uk
Vacancy Published: 17 days ago

Vacancy Description

Senior Regulatory Executive, Pharmaceutical

Location: Wembley (some remote days could be arranged/ agreed)

Type: Permanent

Salary: Upto £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

The Person:

  • Will hold a Degree in a relevant - Life Sciences or related subject
  • 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

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