Senior Director/Executive Director, Regulatory Scientist

4w1 month ago

Eli Lilly and Company

Singapore, SG · Full-time · S$200,000 – S$350,000

About this role

At Lilly, we unite caring with discovery to make life better for people around the world. This Senior Director/Executive Director, Regulatory Scientist role provides leadership and oversight to deliver Asia Pacific regulatory strategies and Win Through Regulatory for assigned assets. The scientist partners across teams and health authorities to enable market differentiation of first-in-class/best-in-class assets.

Day-to-day responsibilities include developing, updating, and executing the Asia-Pacific registration strategy. The scientist initiates and updates regulatory strategy documents by leveraging scientific knowledge and insights from regulatory agency meetings. They review regulator expectations, monitor competitive development programs, and integrate AP regional strategy into global registration strategy.

The role requires close partnership with colleagues across regulatory functions, particularly the global regulatory lead of assigned molecules. The scientist communicates key information to enable seamless execution of AP regulatory strategy and collaborates with Pricing Reimbursement and Access and Value Evidence Outcome teams to support pricing and access strategies.

This senior leadership position drives market differentiation by influencing what data is needed and how it is collected during development. The scientist leads labeling strategy development and updates, using global labelling strategy to influence drug development strategy. This role offers the opportunity to shape regulatory pathways for innovative medicines in the Asia-Pacific region.

Requirements

Advanced degree in a scientific discipline (e.g., PhD, PharmD, MD) or equivalent experience.
Extensive experience in global regulatory affairs within the pharmaceutical industry.
Proven track record of developing and executing regulatory strategies for innovative medicines.
Deep understanding of Asia-Pacific regulatory requirements and health authority interactions.
Experience leading cross-functional teams and influencing drug development strategy.
Strong scientific and clinical development knowledge to support market differentiation.
Ability to communicate complex regulatory information to diverse stakeholders.

Responsibilities

Develop, update, and execute Asia-Pacific registration strategy for assigned assets.
Initiate and update regulatory strategy documents by leveraging scientific knowledge and regulatory agency feedback.
Review, summarize, and present information regarding regulator expectations and monitor competitive development programs.
Integrate AP regional regulatory strategy into global registration strategy and serve as global regulatory coordinator as assigned.
Partner with colleagues across regulatory functions, particularly the global regulatory lead, to deliver integrated AP regulatory strategy.
Collaborate with Pricing Reimbursement and Access (PRA) and Value Evidence Outcome (VEO) teams to support pricing and access strategies.
Lead development and update of labeling strategy to deliver market differentiation.
Drive Market Differentiation as Driver Strategy using tools like Claims Mapping and partner with cross-functional teams.