What are the responsibilities and job description for the Manager - Regulatory Affairs position at ZO Skin Health, Inc.?
Working with the VP, develops and administers regulatory activities for product registration and maintenance for various regions including but not limited to Canada, EU, ASEAN, and Japan and for various product types including cosmetics and OTC drugs.
In collaboration with the VP, manages regulatory team members and provides planning and coordination of submissions and activities; provides technical guidance and mentoring.
Manages and tracks regulatory commitments, deliverables, and submission content to ensure timely and accurate registrations and licenses.
Oversees the review and assessment of ZO products, formulations, raw materials, labeling, product claims, etc.
With guidance from VP, represents regulatory on cross-functional project teams and provides input and recommendations to other departments including R&D and Marketing teams.
Collaborates with international distributors and partners plus internal departments to request, coordinate, and communicate regulatory information.
Assists in monitoring global regulations and guidance's for changes.•Educates and advises internal and external stakeholders on the impact of existing and emerging regulations.
Communicates significant issues or developments identified during regulatory activities and provides recommended process improvements.
Maintains documentation and related systems necessary for efficient operation of the department.
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