Director / Sr. Director of Regulatory Affairs

Director / Sr. Director of Regulatory Affairs

Direct Hire Full-Time Role

Pay Rate: $125 - $135 per hour

Location: Palo Alto, CA - Remote 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. This role is a hybrid model located in Palo Alto, CA.

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 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%)

Preferred Qualifications:

• Previous experience in a life sciences lab, warehouse, or facilities management is highly valued.
• Previous experience using an autoclave.
• Management of manual defrost cycles for -80°C and -20°C freezers.
• Experience with monitoring liquid nitrogen (LN2) levels in the tank and inspecting vacuum-jacketed piping for frost/leaks.
• Familiarity with Laboratory Information Management Systems (LIMS), inventory databases, and MS Office is a plus.

Desired Skills and Experience

Global Regulatory Affairs, Global Regulatory Strategy, Drug Development, Regulatory Submissions, Market Approval, Regulatory Dossiers, Health Authority Interactions, FDA Regulations, EMA Regulations, International Regulatory Requirements, Regulatory Compliance, Regulatory Risk Assessment, Risk Mitigation, Accelerated Submission Strategies, Regulatory Policy, Regulatory Intelligence, Oncology, Pharmaceutical Development, Product Development, Cross-Functional Leadership, Global Regulatory Team Leadership, Stakeholder Management, Strategic Messaging, Regulatory Agency Responses, Legislative and Regulatory Analysis, Program Strategy, Operational Planning, Business Acumen, Team Leadership

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