Select Pharma Recruitment
Regulatory Affairs Manager
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An exciting opportunity for an experienced 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
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Required Skills:
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- 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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