What are the responsibilities and job description for the Regulatory Affairs Specialist position at McBride Research Labs?
Position Summary :
The purpose of the Regulatory and Safety Compliance Specialist role is to support the plant safety, quality, regulatory and licensing programs for cosmetic hair care products. Primary responsibility is to ensure the organization remains up to date on all regulatory and licensing requirements in accordance with company, state, and federal regulations and compliant with all safety programs for plant operations. Develop, implement, and enforce policies and procedures to keep company’s products, processes and physical sites operating in a legal and ethical manner and safe for all employees.
Essential Duties :
Responsible for planning, organizing and implementing strategies and activities to procure regulatory approval for new and revised product lines, while maintaining full quality and regulatory compliance with all standards that govern the design, development, manufacturing and distribution of our products.
- Responsible for regulatory affairs including audit reports, regulatory reporting, compliance assessment and overall enforcement.
- Review artwork and formulations to ensure compliance with regulatory and international standards
- Provide advice to product development team and give guidance on potential compliance issues
- Prepare regulatory documentation for submission to regulatory agencies or to commercial partners. Documentation incudes but is not limited to, label or copy reviews, claim substantiation, formula reviews, SOP’s investigation reports and study protocols.
- Respond to inquiries regarding ingredients, formulations, regulatory issues and associated requirements
- Manage regional products and collaborate with international countries.
- Drive global harmonization of labeling content review by assessing, approving, and releasing of product related labeling and marketing materials.
- Author, prepare, and compile the submission files to obtain market approvals various countries and international regions for approval of hair care products.
- Monitor the global regulatory developments of new regulations, standards, policies, and guidance issued by regulatory authorities that may have an impact to the company.
- Interface, communicate, and coordinate with the FDA, Notified bodies, Competent Authorities, and other regulatory agencies on submissions, approvals and other issues.
- Assist in development, writing, and maintaining regulatory department procedures and process improvements.
- Review and approve product and manufacturing changes to assess regulatory impact.
Lead the plant’s safety and environmental activities with an emphasis on safety and health sustainability. Effectively communicate, deliver, and implement plant, OSHA and Corporate Health and Safety rules and regulations. Administer and support plant safety system management and implement training on topics which include : LOTO, Fall Protection, Behavior Base Safety, New Employee Orientation, Safety Project Reviews, MSDS Management, and other key safety and health initiatives to minimize plant personnel risk while maintaining plant production efficiency. Support the plant environmental management system and implement training on topics which include hazardous and universal waste management, storm water pollution prevention, waste water best practices, recycling and waste minimization.