Director / Sr Director of Regulatory Affairs Lead

Director / Sr Director of Regulatory Affairs Lead

Direct Hire Full-Time Role

Salary Range: $240,000 - $270,000 per year

Location: Palo Alto, CA - Hybrid Role

Job Summary:

We are seeking a dynamic and experienced Director/ Sr Director of Regulatory Affairs to be responsible for developing and implementing global strategies to secure and maintain market approval for product(s) globally (US, EMA, Japan, Australia, Canada). This role 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. 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, and develop and implement accelerated submission strategies.

Duties and Responsibilities:

• Leads the GRT to the development of creative global strategies in line with applicable laws. regulations to achieve business objectives for the development and marketing of 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 the 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.

Requirements and Qualifications:

• 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.
• Required Experience: 10+ years' experience in pharmaceutical regulatory activities, with experience as a lead regulatory strategist in two or more major regions in addition to the US, such as the EU.
• Strong global drug development foundation with business acumen.
• Travel expected (10%)

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