Regulatory Affairs Manager

An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.

Responsibilities:

• Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team
• Have an excellent understanding of and be able to execute activities related to the following key areas;
  • Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
  • Reclassification of Medicines
  • Re-baseline / Remediation dossiers
  • License Transfers (giving away and bringing in) including the due diligence of dossiers
  • Maintenance of Marketing Authorisations including renewals
  • Deficiency responses to authorities
• Interfacing with regulatory authorities to facilitate the approval of submissions
• Work with sites (manufacturing, PV service provider)/appropriate personnel/departments 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 authoritiesfor advice and guidancewhen necessary, and to resolve issuesto achieve the bestpossibleoutcome forthebusiness.
• Maintain up-to-date records and documentation in relation to Marketing Authorisations.
• Carry out dutiesin line with regulatory, commercial, quality and businessneedsand ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
• Supportotherregulatory staff members within the Companywhen necessary.
• Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas
• Any other task given to you by relevant stakeholder in order for you to be able to perform your role

Required Skills:

• 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 Preferable
  • Any other regulatory body submissions Added advantage
• Usage of Submission Gateways and Tools;
  • MHRA Portal
  • Eudralink
  • CESP
  • Exposure to NeeS/eCTD format and electronic submission gateways is preferable.