APAC Regulatory Affairs Leader, Biosolutions

Novonesis; Petaling Jaya; Hybrid; MYR 180,000 - 300,000; Full time

Benefits offered by this job

Global exposure

Collaborative environment

Career development

Inclusion & learning

Job summary

Novonesis is seeking a Regulatory Affairs Manager to lead APAC regulatory initiatives for Human Health Biosolutions, ensuring market access and compliance for Probiotics, Postbiotics, HMOs, and Precision Proteins.

You will coordinate with regulators, drive submissions, and mentor the APAC team in a hybrid setup with occasional travel across the region. The role demands a strong background in biology/biotech and 10+ years in Regulatory Affairs.

Qualifications

• Bachelor’s degree or higher in biology, biotechnology, food science, toxicology, chemistry or related field.
• Minimum 10 years in Regulatory Affairs in FMCG, consumer health, food ingredients or biotech.
• Strong understanding of regional/international regulatory frameworks for food, health and biotech products.
• Experience managing complex regulatory projects across multiple countries.

Responsibilities

• Lead and coordinate the APAC Regulatory Affairs team and drive regulatory priorities.
• Lead regulatory submissions, registrations, and market access for products.
• Coordinate regulatory activities across APAC markets and align with global strategies.
• Develop relationships with regulators, trade associations, and industry groups.
• Monitor regulatory developments and provide strategic guidance to stakeholders.
• Translate global priorities into regional action plans; support NPD initiatives.
• Identify and mitigate regulatory and business risks via Enterprise Risk Management.

Skills

Regulatory affairs

Leadership

Stakeholder engagement

Strategic thinking

English communication

Problem solving

Matrix organization

Education

Bachelor’s degree or higher in Biology / Biotechnology

Job description

Novonesis is seeking a Regulatory Affairs Manager to lead APAC regulatory initiatives for Human Health Biosolutions, ensuring market access and compliance for Probiotics, Postbiotics, HMOs, and Precision Proteins.

You will coordinate with regulators, drive submissions, and mentor the APAC team in a hybrid setup with occasional travel across the region. The role demands a strong background in biology/biotech and 10+ years in Regulatory Affairs.