Professional Summary

Professional Overview

John McMahon is a seasoned Director of Regulatory Affairs with over 10 years of experience driving regulatory strategy and compliance in the pharmaceutical industry. He brings a strong technical background coupled with a proven track record of successfully navigating complex regulatory landscapes to ensure timely product approvals and market access.

Experience Summary

Current Role

As the Director of Regulatory Affairs at Sumitomo Pharma America, Inc., John is responsible for leading the company's regulatory operations and ensuring compliance with global regulatory requirements. In this role, he oversees the preparation and submission of regulatory documentation, manages interactions with health authorities, and provides strategic guidance to cross-functional teams to optimize regulatory pathways and secure approvals for the organization's pharmaceutical products.

Career Progression

Prior to his current position, John held progressive roles in Regulatory Affairs at Humacyte, where he most recently served as the Director. In this capacity, he was instrumental in developing and executing regulatory strategies that enabled the successful progression of the company's clinical-stage regenerative medicine products through the development pipeline. Earlier in his career, John gained valuable experience as a Regulatory Affairs Manager at WEP Clinical and a Medical Writer at IQVIA, where he honed his skills in regulatory writing, submission preparation, and dossier management.

John's academic background includes a Postdoctoral Scholar position at Duke University, where he conducted innovative research in the field of regenerative medicine, further strengthening his technical expertise and scientific understanding.

Areas of Expertise

• Regulatory strategy development and implementation

• Preparation and submission of regulatory dossiers (e.g., INDs, CTAs, NDAs, BLAs)

• Liaison and engagement with global health authorities (e.g., FDA, EMA, PMDA)

• Regulatory risk assessment and mitigation

• Cross-functional collaboration and project management

• Regenerative medicine and advanced therapies

• Pharmaceutical product development and lifecycle management

Professional Impact

Throughout his career, John has demonstrated a strong commitment to driving regulatory excellence and ensuring the timely approval of innovative pharmaceutical products. His contributions have been instrumental in advancing several clinical-stage regenerative medicine therapies, positively impacting patient access and improving healthcare outcomes.

Conclusion

With his extensive regulatory affairs expertise, strategic mindset, and collaborative leadership style, John McMahon is poised to continue making significant contributions to the pharmaceutical industry as the Director of Regulatory Affairs at Sumitomo Pharma America, Inc. His deep understanding of the regulatory landscape, coupled with his passion for driving innovation, make him a valuable asset to the organization and its stakeholders.