Regulatory Affairs Manager/Sr. Reg. Affairs Specialist

Are You Ready for a New Beginning?

We need your talent, knowledge, and dedication to better our world with biology.

Our Purpose Points the Way

At 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. With biosolutions, the possibilities for transformation are endless.

We’re here to better our world with biology.

Join Us as Our New Regulatory Affairs Manager or Sr. Regulatory Affairs Specialist!

Welcome to the Novonesis Plant Biosolutions Regulatory Team

Novonesis seeks an experienced Regulatory Affairs professional to join our U.S. team with primary responsibility in the biopesticide area, including microorganisms, enzymes, and other novel microbial-derived technologies.

In This Role, You’ll Make an Impact By:

• Engaging with our global regulatory team, internal stakeholders, and external partners to develop regulatory strategies and plans to ensure efficient registrations and required documentation for compliant sales, primarily in the U.S.
• Providing regulatory guidance throughout the product life cycle from early assessment through post-launch activities.
• Aligning with global regulatory and across global functions on data requirements to author and ensure high-quality dossiers.
• Developing and implementing strategies for product submissions, preparing regulatory pre-submission documents, and leading submission meetings.
• Managing regulatory submissions to agencies and ensuring timely approval.
• Monitoring, interpreting, and communicating regulatory standards and potential changes to internal regulatory colleagues and key stakeholders.
• Serving as a subject matter expert on agricultural regulations and coordinating regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed.
• Organizing and conducting training sessions to enhance the organization’s knowledge of working in a regulated environment.

To Succeed, You Must Hold:

• Minimum BS (MS preferred) in Life Sciences (Microbiology, Molecular Biology, Biochemistry).
• Minimum 6+ years of relevant regulatory and registration work experience for Sr. Regulatory Affairs Specialist and 9+ years for Regulatory Affairs Manager.
• Experience/knowledge in regulatory affairs, particularly with microbial technologies used for bio-agricultural applications.
• Current experience working within regulatory authorities such as US EPA, FIFRA, USDA, FDA, U.S. state agriculture departments, trade associations, and other industry groups.
• Strong experience in working effectively with external partners and handling highly confidential information.
• Fluent in English (speaking, reading, writing).
• Proven aptitude with a variety of computer disciplines (Microsoft, Veeva).
• Good interpersonal skills and interest in working and interacting with diverse cultures.
• Strong project management, organizational, and communication skills with the ability to manage multiple projects in a team-oriented environment.
• Ability to travel 10-15% within North America with periodic trips to Copenhagen, Denmark.
• Ideally located in the greater Raleigh, NC area; however, other locations will be considered with quarterly travel to Raleigh.
• Ability to work in the U.S. without sponsorship.

Salary Range

• $100,000–125,000 for Sr. Regulatory Affairs Specialist.
• Years of experience will be evaluated for a manager role, with a salary range of $125,000–145,000.

Benefits You Will Enjoy

• 401(k) with up to a 9% company contribution
• Minimum of 3 weeks vacation plus 12 holidays and 2 weeks of wellness time
• Health, dental, vision & life insurance
• Healthcare savings account option with generous employer contribution
• Employee assistance program
• Parental leave
• Tuition reimbursement
• All benefits begin on your first day!

Could Our Purpose Be Yours? Apply Today!

At Novonesis, we commit to an inclusive recruitment process and equality of opportunity for all job applicants. We recommend not attaching a cover letter. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.

Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.

Learn more here