Regulatory Affairs VP

Gan & Lee Pharmaceuticals; Batu Pahat; Hybrid; MYR 616,000 - 1,028,000; Full time

Job summary

A multinational pharmaceutical company is seeking a VP of Regulatory Affairs to oversee regulatory strategies for the U.S. and European markets. This role requires over 15 years of regulatory experience, particularly with FDA and EMA, and expertise in metabolic diseases. Responsibilities include leading a team, developing regulatory submissions, and representing the company in key meetings. The position offers flexibility to work hybrid or fully remote, depending on business needs.

Qualifications

• Minimum 15 years' experience in regulatory affairs.
• Proven leadership in multinational pharma/biotech.
• In-depth regulatory knowledge of metabolic diseases.

Responsibilities

• Develop and execute regulatory strategies for U.S. and EU markets.
• Lead interactions with FDA and EMA.
• Represent the company in regulatory meetings.
• Develop the regional regulatory affairs team.
• Oversee regulatory affairs budgets and processes.

Skills

Deep expertise in FDA and EMA regulations

Strong strategic mindset

Excellent cross-cultural communication

Leadership skills

Fluency in English

Education

Advanced degree in Pharmacy, Medicine, Biology, Chemistry

Job description

Summary

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.

Education and Credentials

• Advanced degree (Master’s or above; PhD preferred) in Pharmacy, Medicine, Biology, Chemistry, or related fields
• Professional certifications in regulatory affairs (e.g., RAC) are preferred

Experience

• 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

Skills

• Deep expertise in FDA and EMA regulations and approval pathways
• Strong strategic and forward-thinking mindset with proven decision-making in dynamic environments
• Excellent cross-cultural communication and negotiation skills
• Exceptional leadership and team-building skills with the ability to inspire international teams
• Proficiency in budget management, process optimization, and organizational efficiency
• 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

Work Location & Flexibility

This position offers flexibility to be based in either Europe or the United States. The role may be structured as hybrid (on-site and remote) or fully remote, depending on candidate preference and business needs.