Sr. Manager - Regulatory Affairs

Description

• Develops and administers regulatory activities for product registration and maintenance for various regions including but not limited to Canada, EU, ASEAN, and Japan and for various product types including cosmetics and OTC drugs.
• Manages regulatory team members and provides planning and coordination of submissions and activities; provides technical guidance and mentoring.
• Manages and tracks regulatory commitments, deliverables, and submission content to ensure timely and accurate registrations and licenses.
• Oversees the review and assessment of ZO products, formulations, raw materials, labeling, product claims, etc.
• Represents regulatory on cross-functional project teams and provides input and recommendations to other departments including R&D and Marketing teams.
• Collaborates with international distributors and partners plus internal departments to request, coordinate, and communicate regulatory information.
• Assists in monitoring global regulations and guidances for changes.
• Educates and advises internal and external stakeholders on the impact of existing and emerging regulations.
• Communicates significant issues or developments identified during regulatory activities and provides recommended process improvements.
• Maintains documentation and related systems necessary for efficient operation of the department.
• Maintains ongoing knowledge of regulatory environment including regulations, guidances, and best practices.

Qualifications

• Bachelor’s degree in a scientific discipline. Advanced degree in a scientific discipline preferred.

Years of experience
10 years of related work experience in cosmetic industry.

Skills and Knowledge

• Strong knowledge of the cosmetic industry including OTC drug categories as well as manufacturing practices.
• Working knowledge of global cosmetic and drug regulations including Food, Drug and Cosmetic Act, Fair Packaging and Labeling Act, 21 CFR 211 Good Manufacturing Practices, as well as EU, Canada, and Asia international cosmetic regulations.
• Excellent managerial, interpersonal, communication and organizational skills; detail oriented.
• Displays leadership, sound reasoning, and can develop innovative approaches to complex issues.
• Excellent technical and problem-solving skills with the drive and ability to both effectively manage a team and do the work.
• Ability to convey complex information in a clear, focused, and concise manner.
• Proactive and self-motivated with a collaborative attitude and a desire to continuously learn.

Salary : $135,000 - $150,000