Manager - Regulatory Affairs
4 weeks ago
The individual will be involved in CMC document review, follow up with all stake holders to achieve quality submissions in timely manner. The individual will thus closely work with the development, quality and plant teams. This individual will also prepare all CMC regulatory documents and coordinate to keep CMC RA database in most updated manner.
What are the key responsibility of the role?
Individual contributor for authoring of CMC sections for IND / IMPD / NDA (CRL resubmission) packages and their life cycle management.
Support in developing and executing the overall regulatory CMC strategies for each supported program as applicable.
Authoring CMC sections for meeting requests / briefing packages for scientific advice meetings.
CMC gap assessment, develop mitigation plan and ensure implementation strategy.
Facilitate and lead all communications with regulatory agencies / health authorities / consultants / internal stake holders, as applicable for CMC related aspects.
Participate in various stage gate meetings for the assigned programs.
Set and monitor submission timelines along with other key stakeholders.
Conduct departmental and cross functional level trainings, as necessary.
Should have sound knowledge of various clinical phases and respective CMC requirements.
Stay abreast of regulatory agency regulations, directives, guidelines and policies etc that could have an impact on product development to assess approval pathways and issues.
Job requirements:
Educational Qualification - M. Pharm / MSc
Good understanding of R&D processes, technology transfer and other CMC topics for API and drug product. Experience of sterile dosage forms is must. The ability to manage competing priorities.
Good communication, presentation skills.
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