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Regulatory Affairs Specialist

Novonesis

Franklinton, NCHybridPosted 1 day ago$75,000 - $85,000/year
Full TimeMid LevelRegulatory AffairsBiotechnology
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Summary

We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs and Product Safety (RAPS) team in Franklinton, reporting to the global function of Regulatory Affairs & Product Safety Operations and Digitalization. In this role, you will help support the regulatory activities that enable Novonesis to produce, sell, import, export, and distribute its products.

Job description

The Role & Your Impact

As a Regulatory Affairs Specialist, you will coordinate customer and regulatory requests, prepare documentation and submissions, and support registrations, certifications, permits, and other regulatory approvals. You'll work closely with internal stakeholders, regulatory colleagues, customers, authorities, and external review organizations to keep routine regulatory activities moving forward accurately and efficiently.

In this role, you'll make an impact by:

  • Managing regulatory and customer inquiries through Salesforce, primarily for enzyme and microbial products in the United States and Canada, delivering timely, accurate, and consistent responses meeting agreed turnaround times.
  • Maintaining accurate, up-to-date regulatory data in Salesforce and related information-management systems to support consistency across regions.
  • Helping improve digital workflows and case-handling practices to increase efficiency and customer satisfaction.
  • Preparing and coordinating documentation for regulatory approvals, registrations and renewals, permits, licenses, certificates, U.S. state registrations, tonnage reporting, and international submissions.
  • Supporting facility, new-product, import, and export-related submissions involving domestic and international authorities.
  • Coordinating third-party product and ingredient reviews, including CleanGredients, Safer Choice, and Green Seal submissions and renewals.
  • Providing operational regulatory support for the Franklinton and Blair sites, including certificates, affidavits, supplier coordination, and regulatory raw-material approvals.
  • Serving as a point of contact for internal stakeholders and external reviewers, participating in regional and customer projects, and continuing to build technical knowledge of Novonesis products.

What You'll Need to Be Successful

  • A bachelor's degree in life science, food science, animal science, chemistry, biology, or a related field, or equivalent relevant experience.
  • 4+ years of relevant experience with a bachelor's degree, 2+ years with a master's degree, or 1+ years with an advanced degree.
  • Experience with regulated industries, including Animal Biosolution, Household Care, or related product and ingredient industries is preferred.
  • Experience with regulatory operations, customer documentation, certification submissions, product registrations, or another regulated environment.
  • Professional written and spoken English.
  • Strong attention to detail and a systematic approach to documentation, data quality, and follow-up.
  • The ability to independently manage routine assignments while following established policies, procedures, and regulatory requirements.
  • Clear, service-minded communication skills and the ability to build effective working relationships with internal teams, customers, authorities, and external partners.
  • The ability to prioritize requests, recognize urgency, and manage multiple activities effectively.

Additional Skills & Interests We Value

  • Experience with Salesforce or a similar electronic information and document management system.
  • Strong digital skills and confidence working with workflow and information-management systems.
  • An interest in continuing to develop technical, digital, and regulatory knowledge in an international organization.

Ways of Working / Working Conditions

  • Location: Franklinton, North Carolina, USA
  • Hybrid working: Office-first hybrid schedule, with a minimum of three days per week onsite and up to two days per week working from home.
  • Collaboration: Work with colleagues and stakeholders across the United States and internationally, including teams in Denmark, India, and China.
  • Travel: Approximately one week of travel to Denmark per year is expected.

Requirements

  • Bachelor's degree in life science, food science, animal science, chemistry, biology, or related field, or equivalent relevant experience
  • 4+ years of relevant experience with a bachelor's degree, 2+ years with a master's degree, or 1+ years with an advanced degree
  • Experience with regulatory operations, customer documentation, certification submissions, product registrations, or another regulated environment
  • Professional written and spoken English
  • Strong attention to detail and systematic approach to documentation, data quality, and follow-up
  • Ability to independently manage routine assignments while following established policies, procedures, and regulatory requirements
  • Clear, service-minded communication skills and ability to build effective working relationships
  • Ability to prioritize requests, recognize urgency, and manage multiple activities effectively

Benefits

  • 401(k) Matching
  • Medical, Dental & Vision
  • Life Insurance
  • HSA Option
  • Employee Assistance Program
  • Parental Leave
  • Tuition Reimbursement
  • Paid Vacation
  • Paid Holidays
  • Wellness Time

Company overview

Novonesis is a global biotechnology leader formed in January 2024 through the historic merger of two Danish bioscience icons, Novozymes and Chr. Hansen. As the world's leading biosolutions partner, the company leverages the power of biology to transform how we produce, consume, and live. With approximately 10,000 employees worldwide, Novonesis operates across more than 30 industries, providing innovative biological solutions that address global challenges in food systems, human health, agriculture, and environmental sustainability. The company's extensive biological toolbox includes enzymes, microbes, probiotics, and functional proteins that enable customers to create more sustainable products and processes. Novonesis serves diverse sectors including food and beverages, household care, agriculture, animal health, and human health, helping businesses reduce chemical use, lower carbon emissions, and improve resource efficiency while delivering better products to consumers. With a strong commitment to sustainability and innovation, Novonesis is positioned to lead the global biosolutions revolution, driving positive change for both business and society.

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