Global Regulatory Affairs VP: Strategy, FDA/EMA Leadership

Gan & Lee Pharmaceuticals; Batu Pahat; Hybrid; MYR 150,000 - 210,000; Full time

Job summary

A global pharmaceutical company is seeking a Vice President of Regulatory Affairs to lead activities in the U.S. and European markets. This role includes overseeing strategy development, ensuring compliance with regulatory bodies, and managing the team responsible for submissions. Ideal candidates will have over 15 years of regulatory experience, particularly with FDA and EMA, and a strong background in managing cross-functional teams. Flexibility in work location is offered, with options for hybrid or fully remote structures.

Qualifications

• Minimum 15 years’ experience in regulatory affairs, including 10 years with FDA/EMA.
• Professional certifications in regulatory affairs (e.g., RAC) are preferred.
• Proven senior leadership in multinational pharma.

Responsibilities

• Develop and execute regulatory strategies for U.S. and EU markets.
• Lead interactions with FDA, EMA, and other authorities.
• Manage and develop the regional regulatory affairs team.

Skills

Expertise in FDA and EMA regulations

Strategic decision-making

Cross-cultural communication

Leadership skills

Budget management

Fluency in English

Education

Advanced degree (Master’s or above)

Job description

A global pharmaceutical company is seeking a Vice President of Regulatory Affairs to lead activities in the U.S. and European markets. This role includes overseeing strategy development, ensuring compliance with regulatory bodies, and managing the team responsible for submissions. Ideal candidates will have over 15 years of regulatory experience, particularly with FDA and EMA, and a strong background in managing cross-functional teams. Flexibility in work location is offered, with options for hybrid or fully remote structures.