Sr Specialist - Regulatory Affairs & Product Safety

Posted 22 Days Ago
Be an Early Applicant
3 Locations
In-Office
105K-110K Annually
Senior level
Biotech
The Role
This role involves U.S. and Canada regulatory activities, providing guidance on regulatory matters, supporting product innovation, and coordinating regulatory submissions.
Summary Generated by Built In

Interested in a career that matters?

Interested in a career that matters?
At Novonesis, we combine biology and science to create solutions that help feed the world more sustainably. Join our North America Regulatory Affairs team and help turn science and regulation into real‑world impact. We enable safe, compliant growth and innovation by translating evolving food regulations into clear, actionable guidance for our commercial and technical teams. You’ll be part of a collaborative, knowledgeable team that supports dossiers, customer questions, product launches, and change management—while continuously strengthening regulatory intelligence, digitalization, and harmonized ways of working across North America.
The Role & Your Impact
As a Regulatory Affairs Senior Specialist, you will support U.S. and Canada regulatory activities that enable compliant business growth, customer support, and innovation. Working under limited direction, you will partner closely with Sales, R&D, Quality, Operations, Supply Chain, and external stakeholders to ensure regulatory requirements are clearly understood and effectively implemented.
Your key responsibilities include:
  • Supporting U.S. and Canada regulatory subject matter activities for relevant food ingredients and segments, including monitoring, interpreting, and communicating regulatory changes and potential business impact.
  • Providing timely, accurate regulatory guidance to internal stakeholders and customers on product status, specifications, labeling/claims, and manufacturing or process considerations.
  • Coordinating and contributing to regulatory dossiers, notifications, and submissions in collaboration with Global Regulatory Affairs and local resources.
  • Supporting innovation and change management, including new products, line extensions, and process changes, by defining compliant pathways and tracking regulatory deliverables.
  • Contributing to industry and trade association interactions, continuous improvement of regulatory processes, tools, and internal training materials.
  • Acting as a digital transformation contributor within North America, including reporting to the business and supporting procurement-related processes.
  • This role has a regional focus (U.S. & Canada) and plays a critical role in balancing compliance, risk, and business needs.
What You’ll Need to Be Successful
Education & Experience
  • Bachelor’s or Master’s degree in Food Science, Food Engineering, Pharmacy, Nutrition, Chemistry, Biology, or another relevant natural science.
  • Typically 4+ years of experience in Regulatory Affairs within the food industry or another regulated industry.
  • Hands-on experience supporting U.S. and/or Canada regulatory deliverables (e.g., ingredients, enzymes, cultures, probiotics, labeling/claims, dossiers or notifications).
Skills & Knowledge
  • Strong understanding of food regulatory frameworks in the U.S. and/or Canada.
  • Excellent analytical and documentation skills with high attention to detail.
  • Strong computer and IT skills, including Microsoft Office.
  • Fluency in English (spoken and written).
Additional Skills & Interests We Value
  • Spanish language skills.
  • Experience working in a global, cross‑cultural environment.
  • Curiosity and learning agility to build expertise across evolving regulatory landscapes.
  • Interest in digital tools, reporting, and process optimization.
Ways of Working
  • Hybrid working model.
  • Collaboration across multiple functions and geographies.
  • Travel required (~30%), primarily within North America.
  • Flexibility to manage priorities in a dynamic regulatory environment.
Compensation & Benefits
The expected base salary for this position is USD 105,000 – 110,000, depending on experience and qualifications.
Our benefits package includes:
  • 401(k) with up to 9% company contribution
  • Minimum of 3 weeks of vacation, plus 12 holidays and 2 weeks of Wellness Time
  • Health, Dental, Vision, and Life Insurance
  • Healthcare savings account option
  • Employee Assistance Program
  • Parental leave
  • Tuition reimbursement
  • All benefits begin on your first day
Relevant Information
Application deadline: 5/22/26

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 Master's degree in Food Science, Pharmacy, Chemistry, or related field
  • 4+ years of experience in Regulatory Affairs
  • Hands-on experience with U.S. and Canada regulatory deliverables
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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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