Global Regulatory Affairs VP Remote/Hybrid Leader

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

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.