Regulatory Affairs Manager, SEA and J&K

Interested in a career that matters?

Interested in a career that matters?
Join Novonesis as Regulatory Affairs Manager, SEA and J&K, supporting market access and regulatory compliance across Southeast Asia, Japan and South Korea. You will be part of our APAC Human Health Regulatory Affairs team, working across technologies including probiotics, postbiotics, Vitamin K, Human Milk Oligosaccharides (HMO), precision proteins and more.

The role & your impact
In this role, you will be responsible for regulatory activities related to Precision Proteins and Enzymes across Southeast Asia, Japan and South Korea. You will help secure market access and regulatory filings, including for complex and novel innovations, while providing regulatory guidance and strategic positioning to internal stakeholders and customers.
You will work across functions and geographies, engaging with health authorities, trade associations and industry forums while translating global regulatory priorities into effective regional execution.

Your key responsibilities in this role

- Secure market access and regulatory filings for Precision Proteins and Enzymes across Southeast Asia, Japan and South Korea, including complex and novel innovations.

- Provide regulatory guidance and strategic positioning to internal stakeholders and customers, while monitoring regulatory trends, changes and emerging policies.

- Lead regulatory advocacy execution across SEA and J&K and engage with regulatory authorities, trade associations and industry forums.

- Coordinate regulatory activities across countries, execute regional regulatory strategies aligned with global priorities, and proactively identify and mitigate regulatory and business risks.

- Drive regional Regulatory Affairs projects and contribute to global projects, working groups and policy initiatives, while embedding digitalization and AI into APAC Regulatory Affairs ways of working.

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 field.

- Minimum 7 years of work experience in Regulatory Affairs, preferably within FMCG, Consumer Health or Ingredients B2B.

- Strong experience working with complex or novel technologies.

- Strong proficiency in English, both written and spoken.

- Proven ability to influence and align diverse stakeholders and drive outcomes without formal authority.

- Strong decision-making capability, balancing regulatory compliance, risk and business objectives in complex situations.

- Excellent communication, negotiation and stakeholder management skills across cultures and geographies.

Additional skills & interests we value

- Experience with genetically modified microorganisms (GMM) is an advantage.

- Strategic thinking combined with strong execution discipline and ownership.

What we offer you
You will join an APAC Human Health Regulatory Affairs team that works across business units and closely with regional and global colleagues. You will work alongside colleagues who share their knowledge and experience, with opportunities to contribute to regional and global regulatory projects and initiatives.

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