Description
Kelly® Science & Clinical is seeking a Regulatory Affairs Manager for a position at cutting-edge client in Raleigh, NC. If you're 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.
Regulatory Affairs Manager
Our purpose points the way
We believe that solutions rooted in biology can address humanity's 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.
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.
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!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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