Senior Regulatory Strategy Lead (Pharmaceuticals, Remote/Asia)

Job summary

This role involves leading global regulatory strategy with a focus on Asia, specifically Japan and China, for a late-stage development project targeting neurological disorders. The position emphasizes aligning global regulatory strategies with local registration requirements and managing life cycle activities for a new drug.

Qualifications

• Advanced degree in life sciences or a medical discipline; PhD preferred.
• Proven experience in global regulatory strategies and health authority interactions.
• Understanding of scientific and value chain processes in drug development, particularly in CNS, biologics, or rare diseases.
• Strong matrix leadership and innovative mindset.
• Excellent communication skills in English, both written and spoken.

Responsibilities

• Strengthen connectivity between global regulatory strategies and local registration needs in Japan and China.
• Lead regulatory activities related to life cycle management prior to drug submission and approval.
• Collaborate with cross-functional teams including clinical leads, biostatisticians, and medical writers.
• Provide strategic input and regulatory expertise, including planning for health authority interactions and evaluating regulatory risks.
• Proactively contribute to the development of the Global Regulatory Strategy function and participate in internal improvement projects.

Skills

• Strong leadership and influencing skills across various organizational levels.
• Innovative thinking in developing regulatory strategies.

Education

• University degree in life sciences or medical field; PhD is advantageous.

Tools

• Familiarity with regulatory submission processes and health authority guidelines.