Role and Responsibilities:
Reporting to the CMC-4 resource, the CMC-3 is responsible for contributing to the development of CMC regulatory strategies for assigned pharmaceutical products and the ability to execute tasks independently in accordance with global regulations and guidance, and Client's procedures to include but not limited to following activities;
1. Pre-Detail Regulatory Assessment (DRA) Activities
2. Post-DRA Activities
3. Conformance Assessments
4. Strategy and Authoring of CMC Content
5. Project Management
6. Performance Metrics Reporting
The CMC-3 will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products and may manage a team of two (2) to four (4) individual contributors in support of project execution.
Typical Accountabilities:
Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead execution of global product and project regulatory strategy(ies)
by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, and responses to health authority questions per established business processes and systems. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with Client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established busine