Manager 1 - Global Regulatory Affairs

How would you describe this position in 2-3 lines?         

1. Regulatory lead will support in providing CMC strategy for drug substance and drug product during different clinical phases. Responsible for product registration, approval and regulatory compliance throughout product life cycle.
2. 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?

1. Support in developing and executing the overall regulatory CMC strategies for each supported program as applicable.
2. Individual contributor for authoring of CMC sections for IND / IMPD / NDA / MAA submission packages and their life cycle management.
3. Authoring CMC sections for meeting requests / briefing packages for scientific advice meetings.
4. CMC gap assessment, develop mitigation plan and ensure implementation strategy.
5. Facilitate and lead all communications with regulatory agencies / health authorities / consultants / internal stake holders, as applicable for CMC related aspects.
6. Participate in various stage gate meetings for the assigned programs.
7. Set and monitor submission timelines along with other key stakeholders.
8. Conduct departmental and cross functional level trainings, as necessary.
9. Should have sound knowledge of various clinical phases and respective CMC requirements.
10. 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 
• Work experience- About 5-8 years of regulatory related experience in related field (experience of US / EU submissions is preferred).
• Good understanding of R&D processes, technology transfer and other CMC topics for API and drug product. Knowledge about sterile dosage forms is desired along with solid oral dosage forms.
• The ability to manage competing priorities
• Good communication, presentation skills.