VP of Regulatory Affairs

• Define and own the global regulatory strategy across all programs, integrating CMC, clinical, and post-approval lifecycle requirements from early development through commercialization
• Lead all regulatory operations including submission strategy, agency interactions, regulatory intelligence, and alignment with evolving global requirements
• Oversee CMC regulatory activities, including authorship strategy, filing execution, manufacturing regulatory alignment, and post-approval change management
• Direct clinical regulatory strategy including IND management, protocol review, clinical submission support, and integration of clinical data into regulatory filings
• Lead end-to-end approval submissions (NDA/MAA equivalents), ensuring high-quality, inspection-ready packages aligned with agency expectations
• Serve as primary liaison with global regulatory authorities, leading meetings, negotiations, and ongoing communications
• Own post-approval regulatory obligations, including labeling updates, periodic reporting, safety submissions, and lifecycle management activities
• Build and scale regulatory infrastructure, including eCTD systems, submission management processes, and global compliance frameworks
• Establish regulatory governance standards, SOPs, and decision-making frameworks to support organizational growth and scalability
• Build and lead a high-performing regulatory organization spanning CMC, clinical, labeling, and regulatory operations functions
• Provide strategic regulatory input into portfolio decisions, business development opportunities, and risk management at the executive level
• Ensure continuous regulatory intelligence monitoring and translation into actionable development and submission strategies

Requirements:

• PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline (or equivalent technical experience)
• 18+ years of progressive regulatory affairs experience in pharma or biotech, including 10+ years in senior leadership roles
• Deep expertise in CMC regulatory strategy for small molecule drug development, ideally including oral solid dosage forms and manufacturing processes
• Proven track record leading regulatory teams across CMC and clinical functions in sponsor organizations
• Demonstrated success leading regulatory submissions resulting in at least one product approval (NDA, MAA, or equivalent)
• Extensive experience managing post-approval regulatory activities, including lifecycle changes, labeling updates, and compliance reporting
• Strong experience engaging with global regulatory agencies, including FDA and other major international authorities
• Deep knowledge of ICH guidelines and global regulatory frameworks
• Strong leadership skills with experience building and scaling regulatory organizations in high-growth or startup environments
• Executive presence with ability to represent the organization in high-stakes regulatory discussions and external engagements
• Strong systems thinking, risk-based decision-making, and ability to operate in complex, fast-moving environments

Benefits:

• Competitive base salary range of $240,000 – $320,000 plus equity options
• Comprehensive health coverage including medical, dental, and vision insurance for employees and dependents
• $1,000 home office stipend for equipment and setup
• $1,200 annual learning and development budget
• $250 monthly wellness stipend for fitness, wellness, and lifestyle expenses
• Unlimited vacation policy and paid holidays
• Four-day weekends for all standard three-day holiday weekends
• Paid “paw-ternity” leave for new pet adoption
• Company equity participation for long-term growth alignment
• Fully supportive, mission-driven, and inclusive work environment.