- Demonstrating strong ownership, initiative and accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
- Actively contributes to strategic discussions and decision-making processes.
- Contribute to the development of CMC regulatory strategies and submission documents for post approval pharmaceutical products with the ability to execute tasks independently in accordance with US, EMA & global regulations and ICH guidance.
- Execute regulatory strategies by leading the authoring and review of global CMC submissions and ancillary documentation to support post-approval supplements/variations, and responses to health authority questions using established business process and submissions tools.
- Collaborate with CLIENT and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
- Coordinate timely and accurate responses to the Regulatory agency questions (RTQs) on CMC content.
- Perform regulatory reviews of technical/development documents such as certificate of analysis (CoA), analytical test methods, specifications, and stability protocol/report/data.
- Assess and communicate potential regulatory risks and product mitigation strategies.
- Identify, communicate and escalate potential regulatory issues to concerned CMC team/management, as needed.
- May manage a team of two (2) to four (4) individual contributors in support of project execution.