Regulatory Affairs Manager APAC

Reposted Yesterday
Be an Early Applicant
2 Locations
In-Office or Remote
10-10 Annually
Expert/Leader
Biotech
The Role
The Regulatory Affairs Manager leads APAC regulatory strategies for Human Health Biosolutions, ensuring compliance and market access, while influencing stakeholders and driving collaboration across regions.
Summary Generated by Built In

Interested in a career that matters?

Join us as our new Regulatory Affairs Manager!

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 responsible for Human Health Biosolutions (HHB). In our department, we are responsible for securing both current and future business for Novonesis by ensuring that all ingredients and product offerings—spanning Probiotics, Postbiotics, Human Milk Oligosaccharides, and Precision Proteins—remain compliant and have seamless market access.

This APAC role focuses on executing regional regulatory strategies aligned with global priorities, enabling one strong, unified voice across Novonesis RA, while fostering close collaboration with local health authorities. You will join a passionate group of colleagues who love what they do and are always ready to share their knowledge and experience. We are part of the Regulatory Affairs and Product Safety (RAPS) organization.

In This Role You’ll Make An Impact By

  • Lead and coordinate APAC team, exercising influence‑based leadership to drive collaboration and deliver on RA priorities.
  • Lead regulatory submissions, registrations, and market access processes for GMM‑derived Precision Proteins, ensuring compliance for current and new innovations.
  • Lead and coordinate APAC regulatory activities across countries, influencing peers and global stakeholders to ensure alignment and delivery.
  • Lead regional advocacy and external engagement, collaborating with regulatory authorities, trade associations, and industry groups while monitoring regulatory trends and communicating business impacts.
  • Driving execution of regional regulatory strategies in line with global priorities, translating strategy into clear, actionable regional plans.
  • Support New Product Development (NPD) by delivering regulatory input and driving regional RA projects in close alignment with global RA teams and policy initiatives.
  • Proactively identify, assess, and mitigate regulatory and business risks through Enterprise Risk Management.
  • Embed digitalization to enhance APAC RA workflows, enabling efficiency, data‑driven insights, and harmonization of RA best practices and systems.

To succeed you must hold:

  • Bachelor’s degree or higher in Biology, Biotechnology, Food science, Toxicology, Chemistry, Biochemistry, Genetic engineering or related field.
  • Min. 10 years’ work experience in Regulatory Affairs, ideally with exposure to FMCG / Consumer Health/ Ingredients B2B.
  • Direct experience and knowledge in Genetically Modified Microorganisms (GMM) are an added advantage
  • Proven track record of effective engagement with internal and external stakeholders.
  • Fast learner with strong sense of ownership, able to work independently and collaboratively in a matrix organization
  • Strong proficiency in English (oral & written).
  • Excellent negotiation, communication and influencing skills.

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

Skills Required

  • Bachelor's degree or higher in Biology, Biotechnology, Food science, Toxicology, Chemistry, Biochemistry, or Genetic engineering
  • Min. 10 years' work experience in Regulatory Affairs, ideally with exposure to FMCG/Consumer Health/Ingredients B2B
  • Direct experience and knowledge in Genetically Modified Microorganisms (GMM)
  • Proven track record of effective engagement with internal and external stakeholders
  • Strong proficiency in English (oral & written)
  • Excellent negotiation, communication, and influencing skills

Novozymes Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novozymes and has not been reviewed or approved by Novozymes.

  • Leave & Time Off Breadth Policies include paid holidays, vacation, sick leave, and generous PTO with floating days, with some locations noting separate vacation and sick leave.
  • Healthcare Strength Provides medical and dental insurance, with coverage described as reasonably priced and of good quality in multiple regions.
  • Retirement Support Offers a 401(k) plan with employer matching and structured retirement benefits referenced across roles and postings.

Novozymes Insights

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The Company
HQ: Bagsvaerd
3,710 Employees

What We Do

Novozymes has combined with Chr. Hansen to become Novonesis: linkedin.com/company/novonesis. This global biosolutions company of 10,000 people is transforming how the world produces, consumes and lives. In 30-plus industries, its biosolutions help businesses meet their needs and the needs of our planet. Novozymes was formed in 2000 when Novo Nordisk split into three companies: Novo Nordisk A/S, Novozymes A/S and Novo A/S. Novozymes was the world leader in biological solutions with a commitment to Rethink Tomorrow. It served 130 markets with enzymatic, microbial and advanced protein solutions. The company’s solutions enabled higher agricultural yields, low-temperature washing, energy-efficient production, renewable fuel and many other benefits. In December 2022, Novozymes and Chr. Hansen entered into an agreement to create a leading global biosolutions partner by combining the two companies. The goal was to unleash the full potential of biosolutions and generate significant value for all stakeholders and society. The combination was completed on January 29, 2024 and Novonesis was born. The name means ‘a new beginning’ and is derived from the Greek word ‘genesis’. It reflects a new era where we’ll better our world with biology. You can find Novonesis on LinkedIn here: linkedin.com/company/novonesis. Novozymes A/S, part of Novonesis Group.

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