Regulatory Affairs Specialist

Interested in a career that matters?

Interested in a career that matters?
The Regulatory Affairs FBB team enables compliant and sustainable market access for Novonesis’ product portfolio. In this role, you will help protect current business and support growth in Japan by enabling timely registrations, providing practical compliance advice, and delivering accurate regulatory support.
You will work closely with APAC and Global Regulatory Affairs colleagues and partner with Commercial, R&D, Quality, Product Stewardship, and Supply Chain to share regulatory intelligence and maintain consistent regulatory positions and documentation.

The role & your impact
As Regulatory Specialist, you will combine Japan-focused regulatory responsibility with broader APAC customer and business support. You will help ensure regulatory inquiries, registrations, assessments, documentation, and customer communications are managed accurately and consistently.
A key part of your impact will be connecting local regulatory requirements with regional and global standards while identifying regulatory changes that could affect existing approvals or future business opportunities.

Your key responsibilities in this role

- Manage submissions of new GMM-derived products in Japan, including generating Japan-specific data, preparing high-quality dossiers, and supporting legal sales, import, and trade protection.

- Represent the company in regulatory interactions with relevant Japanese government authorities and work with industry trade associations on key regulatory topics.

- Assess and monitor regulatory developments, advising global colleagues and business functions on compliance requirements, potential impacts, risks, and opportunities.

- Prepare, review, and maintain regulatory documentation, including regulatory statements, technical documentation, product labels, safety data sheets, and master statement templates covering areas such as allergens, GMO, halal, and country-specific compliance.

- Collaborate with regional and global Regulatory Affairs colleagues and cross-functional partners to maintain consistent regulatory positions, documentation, and product-specific assessments, including effective organization of regulatory documents.

What you'll need to be successful in this role

- Bachelor's degree or higher in Biology, Biotechnology, Food Science, Chemistry, Toxicology, Biochemistry, a related field, or equivalent relevant work experience.

- 3–5 years of relevant experience in Regulatory Affairs, Quality, Product Stewardship, Product Development, Food Safety, or a related area.

- Knowledge of relevant regulations and guidelines for enzyme product registrations.

- Experience preparing regulatory documentation for customer-facing purposes, such as statements and technical datasheets.

- Strong oral and written communication, facilitation, and presentation skills, combined with a professional and customer-focused approach.

- Ability to learn quickly, work independently and collaboratively, take responsibility, manage multiple priorities, and maintain accurate and detailed records.

Additional skills & interests we value
Experience working across regulatory, commercial, scientific, quality, and product-related functions will help you navigate the broad stakeholder environment of this role. An interest in regulatory intelligence, continuous improvement, and translating complex requirements into practical advice will also support your success.

What we offer you
You will join a collaborative regulatory environment with connections across Japan, APAC, and global teams. The role provides opportunities to work across functions and contribute to both day-to-day regulatory support and the long-term compliant growth of the business.

Working conditions
This position is based in Japan and follows a hybrid working model with a working-from-home policy.

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