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Regulatory Affairs Manager at LinkedIn

London, Essex - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

10 Nov, 26

Salary

55000.0

Posted On

07 Oct, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

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

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Responsibilities