Job Description:
Job Summary
The Senior Director, Regulatory Affairs serves as the Global Regulatory Affairs Lead (GRL), responsible for developing and executing comprehensive global regulatory strategies that support the advancement and commercialization of therapeutic programs. This role oversees regulatory submissions, approvals, and compliance across multiple jurisdictions and product life cycles. The position requires strong leadership, strategic insight, and the ability to collaborate effectively with cross-functional teams, senior leadership, and regulatory authorities worldwide.
Key Responsibilities
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Serve as the global regulatory lead and strategic advisor on cross-functional teams, shaping program direction based on regulatory insights.
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Develop and communicate innovative regulatory strategies that align with business and development objectives.
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Lead interactions with Health Authorities (e.g., FDA, EMA, PMDA), including preparation of briefing packages and strategy alignment.
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Guide and mentor cross-functional submission teams, ensuring timely and high-quality regulatory filings.
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Oversee global submissions and lifecycle management, including INDs, BLAs, CTAs, MAAs, and post-approval commitments.
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Utilize enterprise systems to ensure document quality, traceability, and regulatory readiness.
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Write, review, and critically evaluate regulatory documents, demonstrating strong command of scientific and clinical content.
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Direct global clinical trial application activities and ensure compliance with global databases (e.g., Clinicaltrials.gov).
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Lead labeling development and review, incorporating data, regulatory intelligence, and feedback.
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Maintain inspection readiness and ensure all global regulatory applications meet evolving compliance standards.
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Engage and manage external consultants to support specialized regulatory activities.
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Support global inspection-readiness and contribute to the continuous improvement of regulatory processes.
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Mentor and lead Regulatory Affairs professionals, fostering a culture of accountability, collaboration, and innovation.
Qualifications
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Bachelors degree in Life or Health Sciences required; advanced degree (Masters, Ph.D.) preferred.
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Minimum 10 years of experience in the pharmaceutical or biotechnology industry, with 46 years in a regulatory management role.
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Deep understanding of U.S. and global regulatory frameworks and submission processes.
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Proven success in developing and executing strategies for major global submissions and marketing applications.
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Strong project management, problem-solving, and leadership abilities.
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Excellent written and verbal communication skills.
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Experience preparing for and participating in FDA Advisory Committees and EMA Oral Explanation proceedings.
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Ability to navigate complex technical and scientific issues to support data-driven regulatory decision-making.