Regulatory Affairs Manager, APAC

Posted 5 Days Ago
Be an Early Applicant
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, MYS
In-Office
Senior level
Biotech
The Role
Lead regional regulatory strategy and execution across APAC, managing product registrations, submissions, renewals, and variations. Provide regulatory advice, monitor regulations, collaborate with global and local teams and authorities, support inquiries and advocacy, and drive process improvements to enable market access for Novonesis' portfolio.
Summary Generated by Built In

Interested in a career that matters?

At Novonesis, we unlock the power of biosolutions to enable better business with less environmental impact. Our Food & Beverage Biosolutions (FBB) business plays a key role in delivering innovative and sustainable solutions across global markets.
As part of our Regulatory Affairs team in APAC, you will ensure that our portfolio meets regulatory requirements and achieves market access across diverse and dynamic markets. This is a high-impact regional role where you will shape regulatory strategies, enable business growth, and collaborate across global and local teams.
The Role & Your Impact
As a Regulatory Affairs Manager (APAC), you will drive regulatory excellence and ensure that Novonesis’ product portfolio remains compliant and competitive across the region. This role combines strategic planning, operational execution, and cross-functional collaboration.
Your key responsibilities include:
  • Leading regulatory submissions, approvals, renewals, and variations across APAC markets
  • Developing and executing regulatory strategies to enable timely product registrations and market access
  • Providing regulatory advice to business functions and ensuring compliance with local regulations
  • Monitoring regulatory developments and assessing potential business impact
  • Acting as the key interface between APAC and Global Regulatory Affairs teams
  • Collaborating with cross-functional teams, external partners, and authorities
  • Supporting regulatory inquiries, documentation, and advocacy initiatives
  • Driving process improvements and alignment of regulatory tools and systems
What You’ll Need to Be Successful
We are looking for a strong regulatory professional with a strategic mindset and the ability to navigate complex regional regulations.
Required qualifications:
  • Bachelor’s or higher degree in Food Science, Biology, Chemistry, Regulatory Affairs, or a related field
  • Solid experience in regulatory affairs within food, beverage, biotech, or related industries
  • Proven experience managing product registrations and regulatory submissions in APAC markets
  • Strong knowledge of regulatory frameworks across multiple APAC countries
  • Ability to analyze regulatory requirements and translate them into business implications
  • Strong stakeholder management and cross-functional collaboration skills
  • Excellent communication skills in English
Additional Skills & Interests We Value
  • Experience in Food & Beverage, enzymes, or biosolutions industry
  • Exposure to regulatory advocacy or engagement with authorities and industry associations
  • Experience working in a global matrix organization
  • Strong analytical and problem-solving mindset
  • Continuous improvement and process optimization mindset
What We Offer
At Novonesis, we offer more than just a role—we provide an opportunity to make a difference.
  • A purpose-driven company focused on sustainability and innovation
  • A highly collaborative and international work environment
  • Opportunities to shape regulatory strategies and influence market access
  • Continuous learning and career development opportunities
  • A culture that values diversity, inclusion, and scientific excellence
Ways of Working / Working Conditions
  • Office or hybrid setup depending on location
  • Regional role with collaboration across global teams
  • Occasional travel within APAC may be required
  • Dynamic role requiring cross-functional and cross-cultural collaboration

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 or higher degree in Food Science, Biology, Chemistry, Regulatory Affairs, or a related field
  • Solid experience in regulatory affairs within food, beverage, biotech, or related industries
  • Proven experience managing product registrations and regulatory submissions in APAC markets
  • Strong knowledge of regulatory frameworks across multiple APAC countries
  • Ability to analyze regulatory requirements and translate them into business implications
  • Strong stakeholder management and cross-functional collaboration skills
  • Excellent communication skills in English
  • Experience in Food & Beverage, enzymes, or biosolutions industry
  • Exposure to regulatory advocacy or engagement with authorities and industry associations
  • Experience working in a global matrix organization
  • Strong analytical and problem-solving mindset
  • Continuous improvement and process optimization mindset

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: Bagsværd
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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