Vice President, Regulatory Affairs - Remote

Overview

The Vice President, Regulatory Affairs is responsible for developing and directing Partner Therapeutics’ regulatory strategy, objectives, policies, and programs from IND planning through NDA and future commercialization. This position will serve as the regulatory lead for developing and providing strategic regulatory direction and guidance on Company projects and key strategic business initiatives. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including CMC, discovery, preclinical, and clinical as well as for all post-approval obligations.

In Short

• Establishes the strategic vision for Regulatory Affairs and ensures its successful execution.
• Leads the preparation and filing of all regulatory submissions and establishes the strategy for submissions of product registration documents to health authorities worldwide.
• Establishes and maintains excellent relationships with regulatory agency personnel.
• Collaborates with cross-functional teams to ensure regulatory requirements are integrated into development programs and commercial strategies.
• Oversees and directs external regulatory consultants, vendors, and/or CROs.
• Evaluates and manages regulatory risks and establishes regulatory infrastructure.
• Monitors regulatory landscape and communicates new or changing regulatory developments.
• Provides input on clinical trials and filing activities.
• Identifies regulatory operations or processes in need of improvement.
• Manages Regulatory Affairs planning process and budget.

Requirements

• Possesses deep understanding of the patient and stakeholder/customer viewpoint.
• Extensive experience with regulatory filings to the FDA.
• Knowledge of relevant agency guidelines and regulations.
• Demonstrated excellence in regulatory liaison/strategy.
• Strong critical thinking, analytical, and problem-solving skills.
• Excellent soft skills including a bias towards action.
• Strong written and oral English communication skills.
• Solid software skills including Word, Excel, PowerPoint, Outlook.
• Experience with international regulatory submissions preferred.
• Advanced degree (MS/PhD/PharmD) strongly preferred.

Benefits

• Competitive salary range of $264,200 - $362,000.
• Comprehensive medical, dental, and vision insurance.
• 401k matching.
• Paid time off and holiday shutdown.
• Casual and hybrid or remote workplace program.
• Tuition assistance and professional development opportunities.
• Gym subsidy and wellness participation programs.
• Free parking or Seattle-area ORCA pass.
• Annual cash bonuses and pre-IPO options.
• Commitment to diversity and inclusion in the workplace.