Job Description

A rapidly growing oncology biopharmaceutical company is seeking a Senior Director Regulatory Affairs to join the team. This role involves developing and implementing global strategies to secure and maintain market approval for products in all major markets. This person will serve 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. The candidate must demonstrate leadership behaviors to build a cohesive team environment and have a deep understanding of oncology drug development and regulatory requirements. The role also involves developing and implementing accelerated submission strategies.

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.
• Act as a key internal leader and driver of regulatory policy and strategy for assigned products.
• Drive global strategy for products throughout clinical development
• Serve as a POC with global health authorities (FDA, Health Canada, EMA)
• 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.
• 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 preferred
• 10+ years of Regulatory Affairs experience
• Must have experience within oncology
• Extensive experience as a lead regulatory strategist in multiple regions
• Strong global drug development foundation with business acumen.

• Experience in regulatory submissions and regulatory interactions in multiple regions.
• Knowledge of global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable.
• Required Experience: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
• Serve as a mentor for regulatory personnel.
• Travel expected (10%).

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