Senior Director, Regulatory Affairs and Compliance

2 days ago


Cambridge, Massachusetts, United States Apnimed Full time
Job Summary

We are seeking a highly experienced Senior Director to lead our Regulatory Affairs and Compliance team at Apnimed. As a key member of our leadership team, you will be responsible for developing and executing regulatory strategies to support the approval and commercialization of our therapies globally.

Key Responsibilities
  • Regulatory Strategy and Planning: Develop and execute regulatory strategies to support the approval and commercialization of Apnimed's therapies globally.
  • Regulatory Document Preparation: Oversee the preparation, review, and submission of high-quality regulatory documents, including Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Common Technical Document (CTD) modules.
  • Regulatory Agency Interactions: Establish and maintain relationships with regulatory agencies, actively participating in interactions and submissions to secure necessary approvals and licenses.
  • Team Leadership: Lead and manage a team of regulatory professionals to ensure the successful execution of regulatory strategies and plans.
  • Collaboration and Communication: Partner with cross-functional teams within Apnimed and with our colleagues at Shionogi to ensure regulatory requirements are integrated into product development plans.
  • Regulatory Compliance: Ensure compliance with U.S. and global regulatory requirements, including FDA processes, requirements, and guidelines.
Requirements
  • Education: Bachelor's degree in a healthcare-related discipline is required, and an advanced degree in Regulatory Affairs is a plus.
  • Experience: Minimum of 10 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with some experience in a rapidly growing company preferred.
  • Skills: Demonstrated knowledge in the Japanese regulatory environment, proven experience in clinical writing, and a track record of successful regulatory submissions and product approvals in the U.S. and other global markets.
What We Offer
  • Competitive Compensation and Benefits: We offer a comprehensive benefits package, including 401(k) with company match, generous time off for vacation, and flexible working environment.
  • Opportunity to Make a Difference: As a key member of our leadership team, you will have the opportunity to make a significant impact on the development and commercialization of our therapies.


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