Regulatory Affairs Manager
4 days ago
About the Role: Achieva Group Limited is seeking a highly skilled Regulatory Affairs Manager to join our team.
Job Description: The successful candidate will be responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. This includes accountable management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations like variations, notifications, labelling updates, renewals, sunset clause etc across product portfolio.
Main Responsibilities:
- Manage post-approval filings and life cycle maintenance supplements of Marketing Authorisations
- Maintenance of MIA and WDA including API import registration
- Filing strategy and managing submission timelines
- Identifying and remediating compliance gaps if any
- Gather, consolidate, analyse documentation and submit regulatory filings
- Coordinate and prepare written responses to requests for information from regulatory authorities
- Monitor status of regulatory applications
- Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product
- Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction
- Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary
- Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems
- Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products
- Build good working relationships with CMOs and cross-functional teams within the organisation
- Supervise assigned team members with respect to management and training
- Participate in resource planning and recruitment procedure
- Ensure compliance with company policies, procedures and training expectations
About You: To be successful in this role, you should have a salary of approximately £60000 - £80000 per annum. We are looking for someone with understanding of GMP, Quality and Regulatory requirements, communicative and able to work with a range of stakeholders, at all levels, both internally and externally. Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools. Maintaining an awareness of changing regulatory requirements.
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