Regulatory Affairs Director
1 day ago
**Job Title:** Regulatory Affairs Manager
About the RoleThis position is responsible for managing post-approval changes of Marketing Authorisations and product life cycle management. We are seeking a highly skilled and experienced professional to join our team.
Key Responsibilities- Accountable for 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.
- 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.
- 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 changing regulatory requirements.
We offer a competitive salary of £65,000 - £75,000 per annum, depending on experience.
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