Head of Regulatory Affairs ASIA

Responsibilities

• Develop and execute regional regulatory strategies aligned with global business goals for new product development and market expansion.
• Serve as the primary liaison with regional regulatory authorities, managing communications, negotiations, and submission strategies.
• Monitor and anticipate regulatory trends across key markets including China, Japan, India, Korea, ASEAN, and ANZ.
• Lead, manage, and develop a high-performing regional regulatory team through coaching and mentorship.
• Oversee the preparation, submission, and maintenance of regional regulatory filings such as DMF/CDMFs, SMFs, and IDLs.
• Ensure compliance with global standards including eCTD and ICH guidelines.
• Collaborate with R&D, Quality, Clinical, and Commercial teams to integrate regulatory requirements throughout the product lifecycle.

Requirements

• Proven experience in regional regulatory strategy development and team management.
• Deep knowledge of regulatory authorities including NMPA, PMDA, MFDS, CDSCO, HSA, and TGA.
• Extensive experience with regulatory filing oversight (DMF/CDMFs, SMFs, IDLs).
• Strong understanding of eCTD and ICH guidelines.
• Ability to provide expert regulatory guidance to senior leadership and cross-functional teams.

About the Company

Roquette is a family-owned global leader in sustainable plant-based solutions, driving innovation in nutrition, health, and bioindustry. With over 90 years of expertise and 11,000 employees, we harness natural resources to craft high-performance ingredients used in everyday foods, oral medications, and advanced biopharmaceuticals across more than 150 countries.