Regulatory Affairs
5 days ago
Position Summary:
The Regulatory Affairs & Compliance Specialist is responsible for adhering to regulatory affairs policies, processes, and controls for product regulatory and compliance procedures that align with our global sales and development strategy. Day-to-day, the Regulatory Affairs & Compliance Specialist provides guidance on product safety and quality issues, ensuring that products are developed, produced, and labeled in compliance with customer requirements and international safety legislation.
Key Accountabilities, Role and Responsibilities:
● Serve as the regulatory affairs and compliance manager and technologist for cosmetics, toiletries, gifting, and stationery products.
● Collaborate with creative and brand teams to ensure products are researched, developed, risk-assessed, and labeled in compliance with customer protocols, international trading standards, and safety legislation.
● Ensure that products and packaging information include clear instructions, warnings, and disposal guidance.
● Optimize the use of time and resources when advising creative teams on commercial compliance requirements and obtaining quotes for testing or audits.
● Assist in the selection and review of suppliers and factory sites, ensure all audits and GMP certifications are up to date, working collaboratively and assertively with them. Be available for yearly visits to US and Asian suppliers.
● Ensure products are developed with safety, quality, functionality, performance, and sustainability in mind. Collaborate with factories and inspectors to minimize final random inspection and testing failures, thereby avoiding delays in delivery schedules.
● Manage and coordinate the product testing process, reviewing supplier documentation, advising laboratories and suppliers on testing requirements, and agreeing on test plans to ensure a complete technical file/Product Information File is held prior to delivery, and that production is safe and compliant with FDA MoCRA and EU CPSR.
● Ensure product sustainability and sourcing claims comply with legal regulations, customer and standards organization requirements, e.g., PETA, RSPO, and FSC.
● Respond to inquiries from global sales teams by providing evidence of product compliance and addressing non-conforming product issues reported to customer services.
● Support the implementation of company databases related to test reports, Safety Data Sheets, NetSuite, Wercs Studio, and supplier documentation/technical files.
● Set up or update cosmetic listings, UFIs, and notifications for cosmetics in relevant countries (FDA Direct, UK OPSS, EU CPNP, Australia-AICIS).
● Conduct horizon scanning for imminent legislation affecting products and support the compliance team in consistent implementation.
● Contribute to training sessions and support creative/production/sourcing teams in understanding their interaction and collaboration with the compliance team.
● Work closely and collaboratively with the entire Designworks compliance team to ensure consistent adherence to policies and procedures, and to facilitate knowledge and experience sharing.
● Ensure full compliance with the company Health & Safety Policy.
Knowledge Areas:
● Bachelor's, MPS, or other graduate degree in Cosmetics & Fragrance Management, Regulatory or Cosmetic Science, Chemical Engineering or related subject.
● Minimum of 5 years of regulatory affairs or technologist experience working with cosmetics or toiletries.
● Minimum of 2 years of experience in regulatory affairs for Target is preferred.
● Strong knowledge and experience of retailer and customer requirements and protocols, including Target and Walmart.
● Comprehensive working knowledge of applicable regulatory affairs compliance requirements for cosmetics, toiletries, gifting, and stationery in the US, UK, EU, Australia, and Canada.
● Experience of working with testing laboratories such as Biorius, Delphic, TUVR, SGS, Intertek, and BV.
● Knowledge of product recall processes is advantageous.
● Knowledge of product sustainability is advantageous.
● Familiarity with Quality Management Systems such as ISO, BRC, and GMP.
Behaviors & Skills Expectations:
● Communication and Listening: Must be a skilled communicator, capable of active listening and understanding co-workers, leadership, and vendors, addressing their needs appropriately and considering diverse viewpoints. Able to objectively justify own viewpoint and influence outcomes assertively.
● Time Management: Possesses excellent organizational skills with an acute eye for detail, capable of effectively managing time and prioritizing multiple tasks with a sense of urgency.
● Honesty and Integrity: Strives to be ethical in all decisions, committed to the team, products, and company. Demonstrates self-reflection on actions and results, with a commitment to continuous learning.
● Reliability: Accountable for words and actions, including being available to others outside of the assigned work area if needed or assigned.
● Energetic: Exhibits a positive, helpful, and supportive attitude, adapts quickly to change, and demonstrates a drive to succeed.
● Teamwork: Ability to build effective and productive relationships across the company to foster collaboration and achieve results.
● Investigative: Ability to research and gather information, present findings, and clearly communicate and deliver opinions in both written and verbal forms to high standards.
Job Type: Full-time
Pay: $70, $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Relocation assistance
- Vision insurance
Ability to Commute:
- Nashville, TN Required)
Ability to Relocate:
- Nashville, TN 37204: Relocate before starting work (Required)
Work Location: Hybrid remote in Nashville, TN 37204
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