Pamela Danagher
Head of Regulatory Affairs | San Francisco, California, United States
Professional Overview
Pamela Danagher is an accomplished regulatory affairs executive with over 30 years of experience in the pharmaceutical industry. As the Head of Regulatory Affairs at Pathalys Pharma, she is responsible for leading a team of experts in ensuring the company's products comply with all relevant regulations and guidelines, while driving strategic initiatives to streamline the regulatory approval process.
Experience Summary
Current Role
As the Head of Regulatory Affairs at Pathalys Pharma since September 2024, Pamela has been instrumental in navigating the complex regulatory landscape and securing approvals for the company's innovative drug candidates. She oversees the preparation and submission of regulatory filings, coordinates with cross-functional teams, and collaborates with key stakeholders to ensure timely and effective regulatory strategies.
Career Progression
Prior to her current role, Pamela held senior regulatory affairs positions at various leading pharmaceutical companies. She served as the Senior Vice President at Terns Pharmaceuticals, where she led the regulatory team and successfully guided the company through multiple regulatory milestones. Before that, she held the roles of Vice President, Head of Regulatory Affairs and Executive Director at Terns Pharmaceuticals and Takeda, respectively, further honing her expertise in regulatory affairs.
Pamela's earlier career includes positions as Senior Director Regulatory Affairs at Takeda, Director Regulatory Affairs at Amgen, and Senior Director, Regulatory Affairs at Gilead Sciences. She has demonstrated a consistent track record of driving regulatory compliance, optimizing processes, and enhancing the efficiency of regulatory operations.
Academic Background
Pamela holds a Bachelor of Science degree in Cell and Molecular Biology from The American Red Cross Society, where she also conducted research as a Research Associate.
Areas of Expertise
- Regulatory strategy development and implementation
- Preparation and submission of regulatory filings (INDs, NDAs, BLAs, etc.)
- Navigating complex regulatory environments and collaborating with global health authorities
- Developing and maintaining regulatory compliance frameworks
- Cross-functional team leadership and stakeholder management
- Identifying and mitigating regulatory risks
- Implementing continuous improvement initiatives to enhance regulatory operations
Professional Impact
Pamela's regulatory expertise has had a significant impact on the pharmaceutical industry. She has successfully guided numerous drug candidates through the regulatory approval process, contributing to the development and commercialization of life-changing therapies. Pamela's industry contributions include speaking engagements at prominent industry conferences, where she shares her insights and best practices in regulatory affairs.
Conclusion
With her extensive experience, strategic thinking, and exceptional leadership abilities, Pamela Danagher is poised to continue driving regulatory excellence and innovation at Pathalys Pharma. Her dedication to ensuring regulatory compliance and patient safety, coupled with her ability to navigate complex regulatory environments, make her a valuable asset in the ever-evolving pharmaceutical industry.
