Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Ladders; Stati Uniti; Remoto; USD 222.000 - 303.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision coverage

PTO & flexible schedules

401(k) with equity awards

Learning Institute access

ERGs & community engagement

Descrizione del lavoro

Ladders is seeking a Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy to guide regulatory strategies for complex development programs in a remote US-based role.

This senior leader will align regulatory plans with product development and business objectives, working with cross-functional teams and regional leads to anticipate risks and ensure efficient global execution. Responsibilities include leading global regulatory strategy, representing regulatory on Global

Competenze

• Advanced degree in life sciences or related field.
• 10+ years of pharmaceutical/biotech regulatory experience.
• Experience as Global Regulatory Lead for complex development programs.
• Deep knowledge of global drug development and regulatory environments.
• Strong communication and strategic thinking capabilities.

Mansioni

• Lead global regulatory strategy for assigned programs, aligning with product development and business goals.
• Serve as the senior regulatory representative on Global Program Teams, influencing key development decisions.
• Develop and maintain an integrated global regulatory strategy, addressing regional requirements.
• Provide strategic leadership to regional regulatory leads, ensuring alignment with global strategies.
• Identify regulatory opportunities and evaluate risks impacting program objectives.
• Offer strategic input into development plans, including clinical trial strategies and expedited pathways.
• Anticipate changes in the regulatory environment and translate them into actionable recommendations.

Conoscenze

Regulatory strategy

Global regulatory lead

FDA/EMA/PMDA

Cross-functional leadership

Regulatory affairs

Formazione

MS/PhD/PharmD in life sciences

Descrizione del lavoro

For our client, we are seeking a Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy to join the team of a leader in the Pharmaceuticals & Biotech space.

This leader will guide global regulatory strategy for complex development programs, ensuring alignment between regulatory plans, product development, and broader business objectives. The role will serve as a senior regulatory voice on cross-functional program teams and help shape key decisions across the development lifecycle. This position requires strong partnership with regional regulatory leads and close collaboration with internal stakeholders to anticipate risks, identify opportunities, and support efficient global execution.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $222,000 – $303,000 annually

Responsibilities

• Lead global regulatory strategy for assigned programs, aligning with product development and business goals.
• Serve as the senior regulatory representative on Global Program Teams, influencing key development decisions.
• Develop and maintain an integrated global regulatory strategy, addressing regional requirements.
• Provide strategic leadership to regional regulatory leads, ensuring alignment with global strategies.
• Identify regulatory opportunities and evaluate risks impacting program objectives.
• Offer strategic input into development plans, including clinical trial strategies and expedited pathways.
• Anticipate changes in the regulatory environment and translate them into actionable recommendations.

Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in life sciences or a related discipline.
• 10+ years of pharmaceutical/biotechnology regulatory affairs experience.
• Experience as a Global Regulatory Lead for complex development programs.
• Extensive knowledge of global drug development and regulatory environments.
• Significant experience with FDA, EMA, and PMDA interactions and negotiations.
• Strong strategic thinking and problem-solving capabilities.
• Excellent communication skills for conveying complex regulatory issues.

Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• Generous paid time off and flexible work schedules.
• 401(k) plan with competitive company match and annual equity awards.
• Access to a Learning Institute for skill development and mentorship.
• Employee resource groups and opportunities for community engagement.

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.