Regulatory Affairs VP

Gan & Lee Pharmaceuticals

124d

About The Position

This position is responsible for leading Gan & Lee Pharmaceuticals’ regulatory affairs activities in the U.S. and European markets. This role oversees strategy development, submissions, and compliance with FDA, EMA, and other key authorities, ensuring timely approval of innovative medicines. The VP will manage the regulatory team, budgets, and operational processes, while fostering cross-regional collaboration to support the company’s global expansion, particularly in metabolic disease areas.

Requirements

• Advanced degree (Master’s or above; PhD preferred) in Pharmacy, Medicine, Biology, Chemistry, or related fields.
• Minimum 15 years’ experience in regulatory affairs, including at least 10 years directly engaging with FDA/EMA.
• Proven senior leadership experience in multinational pharma/biotech with successful IND/NDA/BLA or MAA approvals.
• In-depth knowledge of regulatory pathways for metabolic diseases (e.g., diabetes, obesity) strongly preferred.
• Familiarity with regulatory requirements across all phases of clinical development (Phase I–III and post-marketing).
• Demonstrated success in complex, matrixed organizations, working effectively with R&D, clinical, commercial, and quality teams.

Nice To Haves

• Professional certifications in regulatory affairs (e.g., RAC) are preferred.
• Deep expertise in FDA and EMA regulations and approval pathways.
• Fluency in English (written and spoken); additional languages such as Mandarin are a plus.

Responsibilities

• Develop and execute regulatory strategies for the U.S. and EU markets, supporting the full product lifecycle from clinical trials to registration.
• Lead interactions with FDA, EMA, and other authorities, ensuring submissions are scientifically robust, complete, and timely.
• Represent the company in regulatory meetings, hearings, and negotiations to enhance visibility in the international regulatory arena.
• Lead and develop the regional regulatory affairs team, including daily management, talent development, and performance evaluation.
• Oversee regulatory affairs budgets, ensuring alignment of resources with corporate priorities.
• Implement and optimize regulatory processes and knowledge databases to drive efficiency and cross-regional collaboration.
• Monitor regulatory policy changes and assess their impact on company projects and commercialization plans.
• Collaborate closely with R&D, clinical, commercial, pharmacovigilance, and quality teams to provide regulatory and market access insights.

What This Job Offers

• Career Level: Executive
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees