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:
* 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.
* 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 relationship with CMOs and cross functional teams within the organisation.
* Supervise assigned team members with respect to management and training.
* Shall participate in resource planning and recruitment procedure.
* Ensure compliance with company policies, procedures and training expectations.
* Performs other appropriate duties, where necessary.
Requirements
Required Skills:
* 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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