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.
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