Job Description

Title: Senior Director Regulatory Affairs

SUMMARY:

A leading biopharmaceutical company is seeking a Sr. Director of Regulatory Affairs. This role involves developing and implementing global strategies to secure and maintain market approval for products in various regions. The position leads the regulatory team, serves as the primary regulatory interface with the product development team and supporting functions, anticipates and mitigates regulatory risks, and ensures compliance with global regulatory requirements.

RESPONSIBILITIES:

• Lead the regulatory team in developing global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Lead cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory agency requests.
• Ensure that organizational goals are met. Act as a key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepare and maintain regulatory risk assessment and mitigation strategy and communicate the plan to relevant stakeholders.
• Act independently and collaborate with senior regulatory leadership. May participate in or lead regulatory and company initiatives.
• Influence the development of regulations and guidance. Analyze legislation, regulations, and guidance and provide analysis to the organization, with worldwide accountability for assigned products.
• Make decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with senior management.

Requirements:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master's degree with at least 10 years of drug development experience. Experience in Oncology is a plus.
• Preferred Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in multiple regions. Strong global drug development foundation with business acumen.

• Travel expected (10%).

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