Job Description

SUMMARY:

Fortvita Biologics is seeking a Director/Sr. Director of Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). Leads the Global Regulatory Team. Serves as the primary regulatory interface with the product development team and supporting functions. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates leadership behaviors to build a cohesive team environment. Must have a solid understanding of drug development, regulatory requirements, Develops and implements accelerated submission strategies.

DUTIES AND RESPONSIBILITIES:

• Leads the GRT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products.
• Leads 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.
• Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.
• Prepares and maintains regulatory risk assessment and mitigation strategy and communicates plan to relevant stakeholders.
• Acts independently and collaborates with the GRA Head. May participate in or lead regulatory and Company initiatives.
• Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.
• Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives as agreed with the senior management.

QUALIFICATIONS:

Qualification Requirements:

• Advanced scientific degree (i.e., PhD, MD, PharmD) or master’s degree with at least 10 years of drug development experience. GRL experience in Oncology is a great plus.
• Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.

Other Information/Additional Preferences:

• Travel expected (10%) .
• Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan.
• Previous regulatory or leadership assignments across multiple countries.
• Industry-related experience in regulatory affairs and/or drug development experience for 10 years.
• Direct experience in clinical and CMC regulatory sciences.
• Experience in applicable therapeutic area (Oncology).
• Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable.
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies.
• Strong written, spoken and presentation communication.
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail.
• Required Experience cont'd: Strong communication and proactive negotiation skills. Experience developing and implementing successful global regulatory strategies.
• Serve as a mentor for GRA personnel.

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