Title: Senior Regulatory Affairs Specialist
Company: Leading Healthcare Companies
Location: Madison, NJ
Type: Permanent Role
Notes: No Corp to Corp
- Work effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations
- Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies
- Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones
- Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
- Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards
- Identify and communicate potential regulatory issues to management, as needed.
- Education Minimum Requirement: Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degreepreferred).
- Previous experience in a CMC position is preferred. Proficiency in additional languages is a plus.