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.

++ Please note that this role will be onsite 5 days per week ++

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 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
• 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.