Regulatory Affairs Manager

Regulatory Affairs Manager

NILES - Niles, IL 60714

Overview

Salary Range $1.00 - $2.00 Salary

Description

The significant responsibilities of the position are listed below. To perform the job successfully, the individual must be able to execute each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties, assignments and specific projects may be assigned at the discretion of management.

Duties and Responsibilities

• Develop and implement regulatory strategies for OTC monograph drug products, cosmetics, dietary supplements, and Class I medical devices.
• Interpret and apply applicable FDA regulations, guidance documents, enforcement policies, and industry standards.
• Assess regulatory impact of new product concepts, formulations, claims, labeling, and packaging.
• Ensure ongoing compliance with FDA requirements and applicable state regulations.

Product Development Support

• Partner with R&D, Marketing, and Quality teams during product development and commercialization.
• Review product formulations, ingredients, specifications, and labeling for regulatory compliance.
• Provide regulatory guidance on product claims, advertising, promotional materials, websites, and digital content.
• Support innovation initiatives by identifying regulatory pathways and requirements for new products.

Labeling & Claims Review

• Lead regulatory review and approval of product labels, packaging artwork, instructions for use, and promotional materials.
• Evaluate structure/function claims, cosmetic claims, OTC drug claims, and device-related claims.
• Ensure labeling complies with applicable FDA regulations and industry standards.

Regulatory Documentation & Submissions

• Prepare and maintain regulatory documentation and compliance records.
• Support FDA registrations, product listings, establishment registrations, and related regulatory filings as required.

Quality & Risk Management

• Collaborate with Quality Assurance to support audits, inspections, investigations, CAPAs, and change control activities.
• Assess regulatory risks and provide mitigation strategies.
• Monitor and communicate regulatory changes that may impact existing or future products.

Cross-Functional Leadership

• Serve as the primary regulatory resource for internal stakeholders.
• Provide training and guidance on regulatory requirements and compliance best practices.
• Support supplier qualification, ingredient reviews, and regulatory due diligence activities.

Post-Market Surveillance & Adverse Event Reporting

• Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
• Evaluate consumer complaints, adverse events, and safety reports for reportability and regulatory impact.
• Ensure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications.
• Partner with Quality, Consumer Relations, and Legal teams to investigate product complaints and safety signals.
• Maintain adverse event documentation, complaint files, and post-market surveillance records in compliance with applicable regulations.
• Monitor product safety trends and recommend corrective and preventive actions when necessary.

Support regulatory inspections, audits, and inquiries related to post-market surveillance and adverse event reporting.

Knowledge, Skills & Abilities

• Strong understanding of FDA regulatory frameworks and enforcement trends.
• Excellent analytical and risk assessment capabilities.
• Ability to interpret complex regulations and translate them into practical business guidance.
• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects in a fast-paced environment.
• Collaborative leadership style with strong stakeholder management skills.

Qualifications

Required Qualifications:

• Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field.
• 5+ years of regulatory affairs experience in FDA-regulated consumer healthcare products.
• Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices.
• Strong knowledge of:
  • FDA OTC Monograph regulations
  • FD&C Act requirements
  • Dietary Supplement Health and Education Act (DSHEA)
  • Cosmetic regulatory requirements under MoCRA
  • Class I Medical Device regulations
  • Product labeling and claims compliance
  • cGMP requirements

Preferred Qualifications:

• Advanced degree in scientific discipline, regulatory affairs, or related field.
• Regulatory Affairs Certification (RAC).
• Experience working with contract manufacturers and private label products.
• Experience supporting FDA inspections and regulatory audits.
• Experience managing adverse event reporting, complaint handling, and post-market surveillance programs for FDA-regulated products.
• Working knowledge of FDA requirements for Serious Adverse Event Reporting (SAER), Medical Device Reporting (MDR), and cosmetic adverse event reporting requirements under MoCRA.
• Experience conducting regulatory assessments of consumer complaints, product safety issues, and reportable events.

Kobayashi Healthcare International