Quality & Regulatory Affairs Manager
Actalent
Quality & Regulatory Affairs Manager
Job Description
The Manager of Quality and Regulatory Affairs will work directly with internal and external teams to ensure that all products meet quality and varying retail standards, are safe to use by consumers, and that any human-related safety or regulatory-related copy claims and endorsements are allowable, tested, and substantiated. This position is responsible for assuring all products comply with applicable US and Canadian regulations and requirements, including but not limited to FDA (Cosmetic, Drug, and Food), EPA, FIFRA, CPSC, and ongoing state-specific regulations and registrations. This individual is expected to be a team player and flex as needed based on broader team needs.
Responsibilities
+ Proactively and positively work with and serve as a resource to the operations, quality, product development, and marketing teams.
+ Onboard new and existing suppliers with Supplier Standards, maintain a repository of documents provided, and ask suppliers for updated documents as needed.
+ Work with internal and external stakeholders to investigate and resolve product quality issues.
+ Collaborate with suppliers and formulators to identify acceptable raw material alternatives and replacements to react to supply chain disruptions and/or identify cost-saving opportunities.
+ Manage and develop regulatory & quality documentation across all products and raw materials (SDS, Formula Cards, Certificates of Analysis, Spec Sheets, Naturally Derived Statements, etc.) with consultative or 3rd party support if needed.
+ Assist in new product development, reviewing all potential raw materials and formulas against key internal and external policies, standards, and regulations.
+ Inform and provide guidance on all labeling and marketing copy and manage internal processes for tracking and substantiation: claims, cautionary statements, use directions, drug facts, DOT regulations, etc.
+ Ensure all products fully comply with related Federal and State regulations (FDA Cosmetics, FDA Drugs, FDA Food, EPA, and Cleaning Product Regulations).
+ Ensure all products and business practices fully comply with varying retailer requirements and coordinate related testing if needed.
+ Ensure all data, product certifications, SDSs, and other key information are loaded into and reflected correctly on our website(s) and other online portals like WERCS, SmarterX, and Label Insights.
+ Relay, manage, and coordinate any required product testing: claims, endorsements (i.e., Clean Label Project, USDA Organic), performance, safety/toxicity, micro, human testing, retail compliance, etc.
+ Manage regulatory-related licenses and registration (i.e., Oregon Board of Pharmacy).
+ Manage product formulation, regulatory, and safety inquiries that come from retailers, consumers, suppliers, or other external parties.
+ Proactively track key regulatory trends (with the help of outside consultants and via participation in trade associations) that could impact the business and summarize potential implications and recommendations regarding these trends.
Essential Skills
+ Regulatory, Quality and/or Operations experience
+ Strong working knowledge of Microsoft Office & Google for Businesses
+ Solid organizational skills and attention to detail
+ Excellent written and verbal communication skills
+ Ability to lead and direct the work of others and manage up if needed
+ Bachelor's Degree in an appropriate field of study or equivalent work experience
INTERESTED CANDIDATES CAN SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
+ Hiring diverse talent
+ Maintaining an inclusive environment through persistent self-reflection
+ Building a culture of care, engagement, and recognition with clear outcomes
+ Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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