Regulatory Affairs Manager in Wharton, New Jersey at DMI Solutions

Position Summary:
The Regulatory Affairs Manager is responsible for leading and managing the Regulatory Affairs function within a cosmetic and OTC manufacturing environment. This role provides strategic and operational oversight for regulatory compliance activities, product labeling, claims review, regulatory submissions, customer regulatory support, and regulatory risk management.
The Regulatory Affairs Manager ensures that products, formulations, manufacturing processes, packaging, and labeling comply with applicable regulatory requirements while supporting new product development, commercialization initiatives, customer requirements, and business objectives. This position serves as the organization's primary regulatory resource and collaborates closely with internal departments, customers, suppliers, and regulatory agencies to maintain compliance and support business growth.
Key Responsibilities:
Regulatory Compliance Management
Develop, implement, and maintain regulatory compliance programs and procedures.
Ensure compliance with applicable FDA regulations, cosmetic regulations, OTC drug requirements, and industry standards.
Interpret regulatory requirements and provide guidance to internal stakeholders.
Monitor regulatory developments and assess potential business impacts.
Develop strategies to address regulatory risks and maintain product compliance.
Serve as the primary regulatory authority for the organization.
Product Compliance & Regulatory Review
Oversee regulatory review of formulations, raw materials, packaging components, labels, and product claims.
Ensure products meet applicable regulatory requirements and customer specifications.
Review and approve labeling, artwork, marketing materials, and promotional claims.
Evaluate regulatory risks associated with product development and commercialization activities.
Provide recommendations regarding compliance strategies and product positioning.
Regulatory Documentation & Submissions
Oversee preparation, review, and maintenance of regulatory documentation.
Ensure regulatory records, technical files, certifications, and compliance documentation remain accurate and current.
Manage product registrations, regulatory submissions, and regulatory reporting activities as required.
Maintain audit-ready regulatory documentation and records.
Coordinate responses to customer, auditor, and regulatory agency requests.
Product Development & Commercialization Support
Provide regulatory leadership for new product development, reformulations, product transfers, and commercialization projects.
Partner with Research & Development (R&D) to evaluate regulatory considerations during product development.
Support project teams by identifying regulatory requirements, risks, and compliance strategies.
Ensure regulatory requirements are incorporated into product development and launch activities.
Support successful commercialization of new products and customer initiatives.
Customer & Regulatory Support
Serve as the primary regulatory contact for customers and external stakeholders.
Support customer regulatory inquiries, questionnaires, audits, and compliance assessments.
Provide regulatory guidance regarding ingredients, formulations, labeling, and product claims.
Maintain strong working relationships with customers and business partners.
Support customer retention and business development initiatives through regulatory expertise.
Regulatory Audits & Inspections
Lead regulatory support activities during customer audits, internal audits, and regulatory inspections.
Coordinate regulatory documentation and responses to audit findings.
Develop and implement corrective and preventive actions (CAPA) related to regulatory observations.
Maintain audit readiness across regulatory processes and documentation.
Support organizational compliance initiatives and inspection preparedness.
Cross-Functional Collaboration
Work with:
Research & Development (R&D) for product development and formulation activities
Quality Assurance (QA) and Quality Control (QC) for quality and compliance initiatives
Operations and Production for manufacturing compliance requirements
Executive Leadership for regulatory strategy and business planning
External customers, suppliers, consultants, and regulatory agencies as needed
Facilitate communication across departments to ensure regulatory compliance throughout the product lifecycle.
Leadership & Employee Development
Lead, mentor, and develop Regulatory Affairs personnel.
Establish departmental goals, priorities, and performance expectations.
Provide training and guidance regarding regulatory requirements and compliance practices.
Support employee development and succession planning initiatives.
Promote a culture of compliance, accountability, and continuous improvement.
Continuous Improvement
Develop and implement initiatives designed to strengthen regulatory compliance programs.
Improve regulatory processes, documentation systems, and compliance workflows.
Support implementation of industry best practices and regulatory technologies.
Identify opportunities to improve operational efficiency and compliance effectiveness.
Drive continuous improvement initiatives within the Regulatory Affairs function.
Qualifications:
Education
Bachelor’s degree in Regulatory Affairs, Chemistry, Biology, Pharmaceutical Sciences, or related field required.
Master’s degree preferred.
Regulatory Affairs Certification (RAC) preferred.
Experience
5–10 years of Regulatory Affairs, Quality, Product Compliance, or related experience required.
3+ years of leadership or management experience preferred.
Experience in cosmetic, pharmaceutical, OTC, personal care, contract manufacturing, or consumer packaged goods (CPG) industries strongly preferred.
Experience working in FDA-regulated manufacturing environments required.
Experience supporting audits, inspections, product launches, and commercialization activities preferred.