Position Summary:
The Director, Regulatory Consultant will be responsible for applying extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.
Essential functions of the job include but are not limited to:
Consulting Services
- Direct the preparation of submissions and other documentation as required for global clearance/approval of in vitro diagnostics, including the preparation of reports and negotiations with regulatory officials as required
- Design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients
- Review and direct the development of analytical and clinical protocols, technical reports and other company documents for use in regulatory submissions and in response to queries from regulatory agencies.
- I... Click Apply to read the full job description.