Kelly Science & Clinical is seeking a Regulatory Affairs Manager for a position at cutting-edge client in Raleigh, NC. If youre passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Location:
The position is ideally located in the greater Raleigh, NC area, with the flexibility to work remotely and travel to Raleigh once per quarter.
Our purpose points the way
We believe that solutions rooted in biology can address humanitys biggest challenges. For over a century, this mission has guided us, driving innovation and impact. Now, more than ever, the world needs change, and biosolutions offer endless possibilities for transformation.
Join us as our new Regulatory Affairs Manager!
About the Team
Our client's Regulatory Team seeks an experienced Regulatory Affairs professional to join the US team, focusing on biopesticides, including microorganisms, enzymes, and other novel microbial-derived technologies. Bilingual candidates (English and Spanish) with experience in registering microbial pesticides in Mexico are highly preferred.
Your impact in this role:
- Engage with global regulatory teams, internal stakeholders, and external partners to develop strategies ensuring efficient product registrations and compliance.
- Provide regulatory guidance throughout the product life cycle, from early assessment through post-launch.
- Align with global regulatory functions on data requirements for high-quality dossiers.
- Develop strategies for product submissions, prepare regulatory documents, and lead submission meetings.
- Oversee regulatory submissions to agencies and ensure timely approval.
- Monitor, interpret, and communicate regulatory standards and changes to colleagues and stakeholders.
- Act as a subject matter expert on agricultural regulations and coordinate regulatory issue resolution.
- Conduct training sessions to enhance knowledge on working within a regulated environment.
Requirements:
- BS/MS in Life Sciences (Microbiology, Molecular Biology, Biochemistry) with 9-11 years of relevant regulatory and registration experience.
- Experience with microbial technologies for bio-agricultural applications and regulatory authorities such as US EPA, USDA, FDA, and COFEPRIS.
- Fluent in English and Spanish.
- Skilled in project management, communication, and handling confidential information.
- Familiarity with various computer applications (Microsoft, Veeva).
- Ability to manage multiple projects in a team-oriented environment.
- Willingness to travel 10-15% within North America and internationally, including periodic trips to Copenhagen.
- Ability to work in the U.S. without sponsorship.
Salary & Benefits:
- Salary range: $125,000 - $145,000
- 401(k) with up to 9% company contribution
- 3 weeks of vacation, 12 holidays, and 2 weeks of Wellness Time
- Health, dental, vision, and life insurance
- Health savings account with employer contribution
- Parental leave and tuition reimbursement
- Employee assistance program
- All benefits start on your first day!