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 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.
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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.
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