Regulatory Affairs Director

4 days ago


Cambridge, Massachusetts, United States ONO PHARMA USA Full time
Job Summary

We are seeking an experienced Regulatory Affairs Director to join our team at ONO PHARMA USA. As a key member of our project teams, you will establish and communicate regulatory strategies for development programs and coordinate the timelines, generation, and submission of complex regulatory dossiers.

Key Responsibilities
  • Manage the planning, preparation, and submission of regulatory dossiers in support of project goals, including developing and maintaining submission plans and timelines.
  • Serve as the Regional Regulatory Lead (RRL) for assigned drug development programs.
  • Lead cross-functional teams to deliver high-quality submissions, such as INDs, NDAs/BLAs, meeting requests, and briefing documents.
Requirements
  • Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.
  • Strong analytical skills and problem-solving capabilities.
  • Excellent communication skills (verbal and written) and ability to effectively communicate with Health Authorities and peer group members from diverse cultural backgrounds.
Preferred Qualifications
  • Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.
  • Ability to negotiate novel development and registration pathways for rare diseases.
Work Environment

The work environment is generally quiet, and the incumbent may occasionally attend meetings at ONO sites and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.



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