Regulatory Affairs Manager APAC

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

Interested in a career that matters? Are you passionate about Regulatory Affairs and interested in working for one of the world’s most sustainable biosolutions companies?

Interested in a career that matters? Are you passionate about Regulatory Affairs and interested in working for one of the world’s most sustainable biosolutions companies? We are looking for a Regulatory Affairs Manager to join our APAC Regulatory Affairs team supporting Human Health Biosolutions (HHB). Our team plays a critical role in enabling current and future business growth by ensuring regulatory compliance and market access for our portfolio, including Probiotics, Postbiotics, Human Milk Oligosaccharides, and Precision Proteins. You will join a collaborative and highly knowledgeable team within the Regulatory Affairs and Product Safety (RAPS) organization, where innovation, partnership, and scientific excellence are at the heart of what we do.

The role & your impact

As Regulatory Affairs Manager, you will lead and drive regulatory initiatives across the APAC region, translating global regulatory strategies into actionable regional plans. You will work closely with internal stakeholders, external regulatory authorities, and industry organizations to support market access, regulatory compliance, and business growth across a rapidly evolving regulatory landscape.

Your Key Responsibilities In This Role

• Lead and coordinate the APAC Regulatory Affairs team, utilizing influence-based leadership to drive collaboration and successful execution of regulatory priorities.
• Lead regulatory submissions, registrations, and market access activities for GMM-derived Precision Proteins and other innovative product platforms.
• Coordinate regulatory activities across APAC markets, ensuring alignment between regional requirements and global regulatory strategies.
• Develop and maintain strong relationships with regulatory authorities, trade associations, and industry groups to support advocacy efforts and market access initiatives.
• Monitor emerging regulatory developments and assess potential business impacts, providing strategic guidance to stakeholders.
• Drive implementation of regional regulatory strategies and translate global priorities into clear regional action plans.
• Support New Product Development (NPD) initiatives by providing regulatory expertise and leading regional regulatory projects.
• Identify, assess, and mitigate regulatory and business risks through effective Enterprise Risk Management practices.
• Promote digitalization and process improvements to enhance regulatory efficiency, data-driven decision-making, and harmonization of regulatory systems and best practices across APAC.

What you’ll need to be successful in this role

• Bachelor’s degree or higher in Biology, Biotechnology, Food Science, Toxicology, Chemistry, Biochemistry, Genetic Engineering, or a related scientific discipline.
• Minimum 10 years of experience in Regulatory Affairs, preferably within FMCG, Consumer Health, Food Ingredients, Biotechnology, or related industries.
• Strong understanding of regional and international regulatory frameworks applicable to food, health, and biotechnology products.
• Demonstrated experience managing complex regulatory projects and driving successful regulatory outcomes across multiple countries.
• Proven ability to effectively engage, influence, and collaborate with internal and external stakeholders.
• Strong business acumen, strategic thinking, and problem-solving capabilities.
• Self-motivated and able to work independently while thriving in a matrix organization.
• Excellent written and verbal communication skills in English.
• Strong negotiation, communication, leadership, and influencing skills.

Additional Skills & Interests We Value

• Experience working with Genetically Modified Microorganisms (GMMs) and related regulatory requirements.
• Prior experience supporting Precision Proteins, probiotics, postbiotics, or other biotechnology-derived ingredients.
• Familiarity with regulatory policy development and advocacy initiatives.
• Experience driving digital transformation, regulatory systems optimization, or data analytics initiatives within Regulatory Affairs.
• Ability to navigate complex and evolving regulatory environments while balancing business objectives and compliance requirements.
• Passion for innovation and continuous improvement

What We Offer You

• A unique opportunity to contribute to sustainable biosolutions that positively impact global health and nutrition.
• Exposure to exciting innovations and emerging technologies within the Human Health Biosolutions portfolio.
• An international and highly collaborative work environment with opportunities to influence regional and global regulatory strategies.
• Professional growth and development opportunities within a global organization.
• A culture built on collaboration, knowledge sharing, inclusion, and continuous learning.

Working conditions

• APAC regional role with extensive collaboration across countries and global functions.
• Hybrid work arrangements subject to local business requirements.
• Periodic travel may be required to engage with regulatory authorities, industry associations, and internal stakeholders.
• Ability to work effectively across multiple time zones and within a matrix organization.

Our purpose guides the way

In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless. If our purpose resonates with you, we encourage you to apply.

Opportunities for everyone

We are committed to an inclusive recruitment process and equal opportunity for all applicants. Therefore we ask you to apply without a cover letter or photo and instead include a few sentences in your CV explaining your motivation for applying.

We make all employment decisions based on business needs and welcome candidates with a wide range of backgrounds, including ethnicity, religion, gender, sexual orientation, age, disability, or veteran status.

Explore Other Openings

If this position isn’t the right fit, you may still find other opportunities with us. You’re welcome to explore open roles or create a job agent to stay connected with future opportunities at novonesis.com/Career