Submission Manager - CMC

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 timely manner and provide direction to assure quality results are produced.
• Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections.
• Coordination of the translation document management activities
• Other miscellaneous regulatory operational activities (e.g., US export waivers, etc.)
• Develop/Update job aid documents for departmental process

Qualifications Experience

• BA/BS degree, science / technology field preferred
• 8+ years relevant submissions experience

Key Competency Requirements

• Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
• Communicates questions and issues as they arise with possible solution
• Supports other functions as appropriate
• Participates in submission team meetings
• Effective written and verbal communication skills
• Works with supervision
• Ability to prioritize and strong attention to detail
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such systems.
• Coordinate non-eCTD submissions with ISL Intercon Team
• Independently prepare Cover Letter, FDA Forms and submission content plan for routine maintenance Investigational submissions
• Coordinate submission publishing with vendor/supplier
• Update Verity with US planned submissions and update entries with submitted submissions
• Perform submission verification on published submissions to confirm eCTD compliant.