Regulatory Affairs Manager

7 days ago


Redwood City, California, United States Corcept Therapeutics Full time
Job Summary

Corcept Therapeutics is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for managing the company's regulatory interface with domestic and international health authorities.

Key Responsibilities
  • Manage the development and deployment of the regulatory program to ensure aggressive product approval
  • Manage and generate regulatory submission documents for new products or changes to existing health authorities' filings
  • Determine governmental regulations affecting company processes and assure the processes are complete and accurate to ensure company compliance
  • Partner with various teams throughout the organization on projects
  • Work with the clinical team to assure appropriate organization and data are used for regulatory submissions and clinical presentations
Requirements
  • 5+ years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
  • Strong analytical and problem-solving skills
  • Strong written and verbal communication skills, including the ability to interact effectively and to influence
  • Strong attention to detail
  • Customer-focused and adaptable, with the ability to balance and manage multiple projects from multiple stakeholders to time and quality expectations
Preferred Qualifications
  • Bachelor's or advanced degree preferred (M.S., Pharm.D., M.D., Ph.D.) in a scientific discipline
What We Offer

Corcept Therapeutics offers a competitive salary and benefits package, including a comprehensive health insurance plan, 401(k) matching, and paid time off.



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