Senior Regulatory Affairs Specialist

  •  

Madison, NJ

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 32 days ago

  by    Michelle Manzon

Job Summary

Title: Senior Regulatory Affairs Specialist

Company: Leading Healthcare Companies

Location: Madison, NJ

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

  • 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.

Requirements:

  • 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.