Regulatory Affairs Coordinator I

Ortho Molecular Products•Stevens Point, WI

18h•$20 - $25

About The Position

Join our team as a Regulatory Affairs Coordinator and play a key role in ensuring our products and processes meet all regulatory standards. This opportunity is perfect for detail‑oriented individuals with a Science or Regulatory Sciences background who are passionate about contributing to the wellness field. Ortho Molecular Products is a leading manufacturer of dietary supplements with over 35 years of stability and success in a team-focused, values-driven culture. Location: Stevens Point, WI or Barrington, IL. This is a part time opportunity, 20 hours per week. What to Expect: Communicate with ingredient suppliers, other external parties, and internal cross-department teams, and evaluate provided documents (e.g., Certificates of Composition, Certificates of Analysis, and general reports) for alignment with existing documentation and regulatory, quality, and company standards. Evaluate product and ingredient documentation for alignment with existing documentation and regulatory, quality, and company standards. Maintain ingredient dossiers and coordinate update cycles. Prepare product dossiers for routine submissions to international import/customs . Perform and initiate document control and retention processes, including reviewing, creating, and maintaining applicable Standard Operating Procedures (SOPs), Work Instructions (WIs) and regulatory records as needed. Implement, organize, and improve regulatory workflows, including templates, review/approval timelines, databases, dashboards, and product/ingredient review cycles. Assist in the design and implementation of other systems and processes to meet regulatory compliance. Evaluate label names and literature for consistency and alignment with existing regulatory precedent and approvals. Monitor trends in the regulatory environment and industry standards

Requirements

Bachelor’s degree in related fields (Health Science, Regulatory/Legal or Food/Nutrition Preferred)
1-2 years of related experience (Food Science, Nutrition, Legal Studies, Regulatory Affairs, Life Sciences)
Strong attention to detail and analytical skills
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions

Nice To Haves

Experience in a cGMP FDA regulated manufacturing facility preferred.

Responsibilities

Communicate with ingredient suppliers, other external parties, and internal cross-department teams, and evaluate provided documents (e.g., Certificates of Composition, Certificates of Analysis, and general reports) for alignment with existing documentation and regulatory, quality, and company standards.
Evaluate product and ingredient documentation for alignment with existing documentation and regulatory, quality, and company standards.
Maintain ingredient dossiers and coordinate update cycles.
Prepare product dossiers for routine submissions to international import/customs .
Perform and initiate document control and retention processes, including reviewing, creating, and maintaining applicable Standard Operating Procedures (SOPs), Work Instructions (WIs) and regulatory records as needed.
Implement, organize, and improve regulatory workflows, including templates, review/approval timelines, databases, dashboards, and product/ingredient review cycles.
Assist in the design and implementation of other systems and processes to meet regulatory compliance.
Evaluate label names and literature for consistency and alignment with existing regulatory precedent and approvals.
Monitor trends in the regulatory environment and industry standards

Benefits

$20 - $25 /Hourly depending on experience and qualifications.
Bonus Program
Health, HSA, Dental, and Vision Insurance : Comprehensive coverage to meet your needs.
Life Insurance (company provided): Ensuring peace of mind for you and your loved ones.
401(k) Plan : With company matching to help you plan for the future.
Health Savings Account (HSA) : With company contributions to support your healthcare expenses.
Paid Time Off : Start with 15 days of PTO annually.
Paid Holidays : Enjoy time off for recognized holidays.
On-Site Wellness Meals : Company-paid meals to support your health.
Gym Membership Reimbursement : Encouraging your fitness and well-being.
Employee Assistance Program (EAP) : Access to confidential support services.
Voluntary Benefits : Options including short-term disability, life insurance (whole/term), hospital indemnity, critical illness, and accident expense coverage.
Growth and Development Opportunities : Access to company university and tuition reimbursement programs.
On-Staff Health Coach : Personalized coaching available one-on-one or in groups.
Health and Wellness Initiatives : Participate in walking challenges, weight loss programs, health risk assessments, and more!