This position is responsible for post-approval changes of Marketing Authorisations and product life cycle management.
Tasks
Duties inclusive but not limited to the below:
1. 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.
2. Maintenance of MIA and WDA including API import registration.
3. Filing strategy and managing submission timelines.
4. Identifying and remediating compliance gaps if any.
5. Gather, consolidate, analyse documentation and submit regulatory filings.
6. Coordinate and prepare written responses to requests for information from regulatory authorities.
7. Monitor status of regulatory applications.
8. Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
9. Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction.
10. Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
11. Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.
12. 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.
13. Build good working relationships with CMOs and cross-functional teams within the organisation.
14. Supervise assigned team members with respect to management and training.
15. Participate in resource planning and recruitment procedure.
16. Ensure compliance with company policies, procedures and training expectations.
17. Perform other appropriate duties, where necessary.
Requirements
Required Skills:
1. Understanding of GMP, Quality and Regulatory requirements.
2. Communicative and able to work with a range of stakeholders, at all levels, both internally and externally.
3. Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
4. Maintaining an awareness of changing regulatory requirements.
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