Principal Regulatory Affairs Specialist

Posted 3 Days Ago
Be an Early Applicant
3 Locations
In-Office
110K-130K Annually
Senior level
Biotech
The Role
The Principal Regulatory Affairs Specialist ensures compliance with food regulations, leads regulatory submission projects, and collaborates with Sales and various stakeholders to drive growth in North America.
Summary Generated by Built In

Interested in a career that matters?

Join our Americas Regulatory Team and play a key role in enabling compliant innovation, supporting local growth, and unlocking export opportunities across North America. In this role, you will act as a trusted partner to the business—bridging regulatory requirements with commercial strategy to ensure safe, compliant, and competitive solutions.

You will help position Regulatory Affairs as a proactive, value-adding function while defining pathways that empower innovation and effectively manage risk.

The Role & Your Impact

As part of the Americas Regulatory team, you will support the HHB business by driving regulatory compliance and enabling growth through strong partnership with Sales and cross-functional stakeholders.

In this role, you will:

  • Act as a strategic partner to North America Sales and provide regulatory insights for key customers

  • Lead regulatory submission projects (e.g., GRAS, NDI, NHPD)

  • Serve as the subject matter expert for U.S. and Canadian regulations

  • Provide regulatory guidance to Sales, Business Support, and QA, particularly for strategic accounts

  • Monitor regulatory changes and communicate risks and business impacts

  • Engage with regulatory authorities, industry groups, and trade associations

  • Drive continuous improvement of regulatory processes and ways of working

  • Support new product development (NPD) activities relevant to the Americas

What You’ll Need to Be Successful
  • Bachelor’s or Master’s degree in Food Science, Natural Sciences, or a related field (Master’s preferred)

  • Minimum of 5 years of experience in Regulatory Affairs within the Food or Drug industry, 7 years preferred

  • Proven experience owning U.S. or North American regulatory deliverables for B2B and/or B2C 

  • Strong knowledge of North American food regulations, including Canadian regulations

  • Understanding of global food regulatory frameworks

  • Strong communication and stakeholder management skills

Additional Skills & Interests We Value
  • Experience working in global, cross-functional environments

  • Ability to translate complex regulatory requirements into practical business guidance

  • Interest in innovation, change management, and process improvement

  • Experience engaging with government authorities or industry associations

What We Offer
  • Opportunity to work in a global, purpose-driven organization focused on innovation and biosolutions

  • A collaborative environment where Regulatory Affairs is a strategic business partner

  • Exposure to global stakeholders and cross-functional projects

  • Opportunities for professional growth and development

Ways of Working / Working Conditions
  • This role is fully remote or can be performed in a hybrid model from one of our sites

  • Collaborative, cross-functional work environment across global and regional teams

  • Regular engagement with internal stakeholders, external partners, and regulatory authorities

  • Role may require participation in industry forums or regulatory engagements

Compensation & Benefits
  • Expected salary range: $110,000 - $130,000

  • 401(k) with up to a 9% company contribution 

  • Minimum of 3 weeks of vacation plus 12 holidays and 2 weeks of Wellness Time  

  • Health, Dental, Vision & Life insurance   

  • Healthcare savings account option  

  • Employee assistance program

  • Parental leave 

  • Tuition reimbursement

  • All benefits begin on your first day

Relevant information
  • Application deadline: June 23, 2026

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, Natural Sciences, or related field (Master's preferred)
  • Minimum 5 years of experience in Regulatory Affairs within Food or Drug industry
  • Proven experience owning U.S. or North American regulatory deliverables for B2B/B2C
  • Strong knowledge of North American food regulations, including Canadian regulations
  • Strong communication and stakeholder management 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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