Regulatory Compliance Project Manager

IMAGE Skincare; Town of Florida (NY); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

9 Paid Holidays

Medical, Dental, Vision and Life

Job summary

IMAGE Skincare seeks a Regulatory & Compliance Project Manager to coordinate regulatory activities, product registrations, and packaging compliance for domestic and international markets. You will partner with Product Development, Marketing, Operations, and Leadership to manage cross-functional projects from initiation to execution, ensuring timelines and regulatory requirements are met.

The role covers MoCRA compliance, documentation, and support for product launches, with a focus on risk

Qualifications

• Bachelor's degree in regulatory/quality fields or related discipline.
• PMP certification preferred; RAC preferred.
• 5+ years in Regulatory Affairs, QA, Compliance, or PM.

Responsibilities

• Lead cross-functional regulatory and compliance projects from initiation to completion.
• Develop project timelines, milestones, deliverables, and dependencies.
• Coordinate with Regulatory, QA, Product Development, Operations, Packaging and Marketing.
• Organize meetings; track decisions, actions, responsibilities and deadlines.
• Identify risks and implement mitigation strategies for delays or gaps.
• Provide executive status reports with risks, issues, and recommendations.
• Support MoCRA compliance and regulatory submissions for domestic and international markets.
• Manage packaging artwork reviews and regulatory reviews for launches.

Skills

Regulatory Affairs

Project Management

Cross-functional Leadership

MoCRA & FDA Regulations

Education

Bachelor's Degree in Regulatory Affairs, Chemistry, Biology, Engineering, Quality Assurance, Business Administration, Project Management, or a related field

PMP Certification

Regulatory Affairs Certification (RAC)

Job description

The Regulatory & Compliance Project Manager is responsible for supporting and coordinating regulatory and compliance activities and cross-functional projects to help ensure IMAGE Skincare products and business activities meet applicable domestic and international regulatory requirements. This role will support regulatory activities including product registrations, notifications and licensing, regulatory documentation, product claims reviews, MoCRA requirements, packaging compliance, and other strategic regulatory initiatives.

The Regulatory & Compliance Project Manager partners closely with Product Development, Marketing, Packaging, Operations, Supply Chain, International, Education, and Executive Leadership to manage assigned regulatory and compliance projects from initiation through execution while ensuring timelines, deliverables, documentation, and compliance requirements are met. The role will also support and coordinate packaging artwork management and related regulatory reviews and may provide project management support for Quality initiatives as needed.

Duties and responsibilities

Regulatory Project Management

• Lead cross-functional regulatory and compliance projects from initiation through completion.
• Develop, maintain, and monitor project timelines, milestones, deliverables and dependencies.
• Coordinate activities between Regulatory Affairs, Quality Assurance, Product Development, Operations, Packaging, Marketing, and external partners.
• Organize and facilitate project meetings and ensure decisions, action items, responsibilities, and deadlines are clearly documented and tracked.
• Identify project risks and implement mitigation strategies to prevent delays or compliance gaps.
• Provide executive-level project status reporting, including key risks, issues, and recommendations as appropriate.
• Identify and implement opportunities to improve project execution, visibility, and cross-functional collaboration.

Regulatory Compliance

• Monitor, research, interpret, and communicate changes in federal, state, and international regulations impacting cosmetic, skincare, OTC, personal care, labeling, and packaging requirements.
• Review products, labeling, packaging, claims, and marketing materials for compliance with applicable regulatory requirements.
• Coordinate and respond to routine regulatory and technical documentation requests from internal teams, distributors, retailers, and other business partners.
• Work with external regulatory consultants, Responsible Persons, manufacturers, suppliers, laboratories, and other partners to obtain information and documentation necessary to support regulatory activities.
• Support product registrations, notifications, listings, and other regulatory submissions for domestic and international markets.
• Support ongoing compliance with MoCRA and other applicable federal, state, and international regulatory requirements.
• Oversee regulatory documentation requests and submission requirements.
• Maintain regulatory records, databases, trackers, and compliance files.

Product Launch & Commercialization Support

• Manage regulatory activities related to new product launches, reformulations, and product or packaging changes.
• Coordinate the regulatory review and approval of product labeling, packaging artwork, ingredient declarations, claims, and other required labeling content.
• Coordinate cross-functional artwork reviews, revisions, approvals, and timelines to support accurate and timely execution.
• Ensure regulatory requirements and approvals are completed in alignment with product launch and commercialization timelines.
• Work closely with Product Development, Marketing, Packaging, and Operations to facilitate timely commercialization and implementation of product and packaging changes.

Documentation & Reporting

• Maintain project plans, compliance trackers, regulatory databases, and required documentation.
• Prepare reports, dashboards, and project updates for leadership as needed.
• Ensure timely completion and retention of required regulatory and project documentation.
• Support continuous improvement of project management processes within the Regulatory & Compliance function.
• Assist in the development and administration of compliance-related training as needed.
• Promote awareness of applicable regulatory requirements throughout the organization.
• Recommend process improvements to enhance compliance, efficiency, and project execution.
• Participate in special projects and strategic initiatives as assigned.

Qualifications

Education

• Bachelor's Degree in Regulatory Affairs, Chemistry, Biology, Engineering, Quality Assurance, Business Administration, Project Management, or a related field required.
• PMP Certification preferred.
• Regulatory Affairs Certification (RAC) preferred.

Experience

• 5+ years of experience in Regulatory Affairs, Quality Assurance, Compliance, Project Management, or related field.
• Experience within the cosmetics, skincare, OTC, personal care, pharmaceutical, or consumer packaged goods industry preferred.
• Proven experience managing complex cross-functional projects.
• Experience supporting regulatory audits, inspections, and compliance initiatives.
• Knowledge of FDA regulations, MoCRA requirements, cGMPs, and international cosmetic regulations preferred.

Success Metrics for this Role

• On-time completion of regulatory projects and product launches.
• Successful audit outcomes and corrective action completion.
• Compliance with domestic and international regulatory requirements.
• Reduction in project delays and compliance-related risks.
• Effective cross-functional communication and stakeholder satisfaction.
• Continuous improvement of regulatory processes and documentation systems
• Strong project management and organizational skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• High attention to detail and accuracy.
• Strong analytical, problem-solving, and decision-making abilities.
• Ability to influence and collaborate across departments without direct authority.
• Advanced Microsoft Office proficiency, particularly Excel, PowerPoint, and Project Management software.
• Experience with SharePoint, quality management systems, and project management platforms preferred.
• Ability to handle confidential and sensitive information professionally.

Physical requirements

• Ability to remain seated and work at a computer workstation for extended periods.
• Ability to occasionally stand, walk, bend, stoop, and move throughout office and warehouse environments.
• Ability to lift and carry materials, product samples, records, or files weighing up to 25 pounds.
• Manual dexterity sufficient to operate computers, office equipment, and electronic devices.
• Visual ability to review technical documents, regulatory submissions, packaging artwork, and electronic reports.
• Ability to communicate effectively in person, by telephone, and through virtual meetings.
• Occasional movement throughout warehouse, production, and laboratory environments may be required.

Working Conditions

• This position is fully onsite at IMAGE Skincare's corporate headquarters in Lantana, Florida, Monday through Friday.
• Primarily operates in a professional office environment.
• Regular interaction with cross-functional teams, vendors, regulatory agencies, and external partners.
• May require occasional travel to manufacturing facilities, suppliers, testing laboratories, trade events, or audit locations.
• Requires flexibility to support critical project deadlines, audits, product launches, and business initiatives.
• Frequent use of computers, video conferencing platforms, and project management systems.

Benefits Available:

• 9 Paid Holidays
• Medical, Dental, Vision and Life Insurance (after 30 days of employment)