Senior Director, Corporate Counsel, Global Regulatory Affairs

📋 Description

• Serve as principal legal advisor to Global Regulatory Affairs, providing risk-based guidance on
• Support legal and regulatory activities throughout product lifecycle, including clinical
• Advise on global regulatory strategy, expedited pathways, orphan drug designations, pediatric
• Provide strategic legal advice on labeling development, negotiation, and implementation across
• Advise on pharmacovigilance, adverse event reporting, safety signal management, risk management
• Collaborate with cross-functional teams (Legal, Compliance, Quality, Clinical, Medical Affairs

🎯 Requirements

• Juris Doctor (J.D.) from accredited law school and active membership in at least one U.S. state
• At least 12 years of post-J.D. legal experience in pharmaceutical, biotechnology, biologics, or
• Deep knowledge of FDA regulations covering drug/biologic development, approvals, labeling
• Strong commercial awareness and ability to deliver practical, risk-based legal advice in highly
• Exceptional communication and stakeholder management skills, with ability to influence senior
• Preferred: previous FDA experience, in-house regulatory affairs support in biotech/pharma, global

🎁 Benefits

• Strategic leadership opportunity influencing regulatory strategy and product lifecycle management.
• Meaningful patient impact through development of treatments for rare genetic diseases.
• Collaborative environment with multidisciplinary experts across legal, regulatory, clinical, and
• Professional growth with exposure to global regulatory challenges and senior-level decision-making.
• Flexible work arrangements: hybrid in San Rafael, CA preferred; remote possible for DC-area
• Compensation and benefits (salary, bonus, healthcare, retirement, PTO) to be confirmed with hiring