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Regulatory Affairs Director

2 months ago

Maidenhead, Windsor and Maidenhead, United Kingdom Select Pharma Limited Full time
Job Description

**Regulatory Affairs Manager**

We are seeking an experienced Regulatory Affairs Manager to join our team at Select Pharma Limited. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the approval of submissions.

Key Responsibilities:
  • Post-approval and compliance activities, including variations, reclassifications, and license transfers.
  • Interfacing with regulatory authorities to facilitate the approval of submissions.
  • Work with sites and personnel to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
  • Act as the primary contact point for Regulatory Affairs with the business units, customers, and other internal/external teams.
  • Stay informed about new and changing regulatory requirements and ensuring compliance.
  • Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
  • Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
  • Maintain up-to-date records and documentation in relation to Marketing Authorisations.
  • Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
  • Support other regulatory staff members within the Company when necessary.
  • Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
Requirements:
  • Pharmacy/Chemistry degree.
  • 7-10 years Regulatory Affairs experience.
  • Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
  • Experience with Generic products and MRP/DCP submissions is advantageous.
  • Clear understanding and ability to manage National Procedure (MHRA), MRP, DCP.
Desirable:
  • Any other regulatory body submissions.
  • Usage of Submission Gateways and Tools; MHRA Portal, Eudralink, CESP.
  • Exposure to NeeS/eCTD format and electronic submission gateways is preferable.