Job Description

Title: Senior Director Regulatory Affairs

SUMMARY:

A pharmaceutical company is seeking a Director/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. The candidate must demonstrate leadership behaviors to build a cohesive team environment and have a solid understanding of 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.
• 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%).
• Experience in regulatory submissions and regulatory interactions in multiple regions.
• Previous regulatory or leadership assignments across various countries.
• Industry-related experience in regulatory affairs and/or drug development for 10 years.
• Direct experience in clinical and Chemistry, Manufacturing, and Controls (CMC) regulatory sciences.
• 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.

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