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Position Overview
The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.
Essential Duties
Include but are not limited to the following:
- Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances.
- Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed.
- Control and maintain regulatory records.
- Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.
- Manage distributors and RA consultants to ensure global registrations are completed on time and maintained.
- Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
📌 Lead Regulatory Affairs Manager, International (Milano)
🏢 Exact Sciences
📍 Milano
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