Job Description:
Job Summary
The Director of Regulatory Affairs is responsible for developing and executing global regulatory strategies, overseeing life cycle management, and ensuring compliance with all applicable regulatory requirements. This role involves managing submissions and approvals for various applications, including INDs, BLAs, CTAs, MAAs, Amendments, PIPs, and Designations, while maintaining post-approval commitments. The Director will collaborate with cross-functional teams, internal leadership, external consultants, and global regulatory authorities to drive successful regulatory outcomes.
Key Responsibilities
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Develop and communicate innovative regulatory strategies aligned with project and business objectives.
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Plan and execute multiple complex regulatory submissions with clear understanding of priorities, timelines, and interdependencies.
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Ensure regulatory applications (U.S. and global) remain current and compliant with evolving requirements.
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Write, review, and critically evaluate regulatory documents with strong command of scientific and clinical content.
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Manage interactions and meeting preparations with regulatory authorities.
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Oversee global clinical trial application (CTA) processes, ensuring compliance and timely submissions.
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Provide oversight for external regulatory vendors and resources.
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Support labeling teams in developing and reviewing labeling content based on data, regulatory intelligence, and feedback.
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Maintain approved marketing applications, including annual reports, supplements, and post-marketing compliance activities.
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Participate in global inspection readiness and share regulatory intelligence on emerging developments.
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Supervise and mentor regulatory staff, promoting professional development and career growth.
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Collaborate cross-functionally to ensure successful execution of regulatory objectives that support product development and patient access.
Qualifications
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Bachelors degree in Life or Health Sciences required; Masters or Ph.D. preferred.
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810 years of experience in the pharmaceutical or biotech industry, with at least 8 years in a regulatory management role.
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Strong knowledge of U.S. and international regulatory requirements and guidelines.
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Proven experience leading major global submissions for marketing applications.
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Demonstrated ability to develop regulatory strategy and implement effective action plans.
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Skilled in project management, leadership, and cross-functional collaboration.
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Excellent written and verbal communication skills, with the ability to convey complex information clearly.
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Experience preparing for FDA Advisory Committee and EMA Oral Explanation proceedings preferred.
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Strong analytical and decision-making skills with attention to detail and compliance.