Specialist, Regulatory Affairs

About the role

The Regulatory Affairs Specialist will support registration/regulatory needs to maintain and further develop the regulatory capability, support global innovation projects, and address business issues to meet business goals.

Responsibilities

• Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards
• Author technical documents for products to be distributed in the EU
• Prepare international documentation to support product registration internationally
• File all new product notifications and update current notifications with Health Canada
• Maintain regulatory archives and product registration databases
• Gather raw material documentation for all JPMS raw materials that could be used in JPMS products and ensure documentation is complete and up to date
• Review documentation received from Manufacturers regarding finished products and file where appropriate
• Keep abreast of evolving regulations to support our product development and commercialization efforts
• Conduct regulatory assessments of product formulas, packaging, and labeling to ensure compliance with local and international regulations
• Collaborate with quality assurance and R&D teams to ensure compliance with applicable Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards

Requirements

• Skills: Ability to manage multiple regulatory projects with concurrent or competing deadlines while working closely with other team members and departments, Strong knowledge of federal regulations, Working knowledge of EU and other international regulations, Knowledge of product labeling and related requirements, Strong experience and knowledge using Microsoft Word, Excel and basic operating systems, Excellent communication skills (verbal and written), Ability to operate in a fast-paced environment

Qualifications

• Education: High school diploma or GED required
• Experience: 3+ years’ experience in Regulatory Affairs, Experience with the preparation and submission of regulatory documents, such as product registration dossiers and technical files, as well as label review

Preferred Qualifications

• Previous experience using Project Lifecycle Management (PLM) systems (Optiva/Infor)
• International experience and global knowledge of cosmetic legislation/registration frameworks