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Submission Manager-I -CMC
Position Summary
Regulatory Information and Submission Management (RISM)
is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and provides submission strategies for drug development, drug approval, and maintenance of market approvals and RISM sets the strategic business direction and related processes oversight for GRS systems.
The Submission Manager-I supports the planning, organization, and review of routine submissions for chemistry, manufacturing and controls (CMC) and regulatory.
Key Responsibilities
- Manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities. Tracks, collects and reviews all components for routine submissions to Health Authorities
- Support the execution of the Global Submission Plan through collaborating with team members and vendors.
- Tracks progress of all components for submission to Health Authorities.
- Interacts with responsible parties to aid in ensuring that components are received in a