Regulatory Affairs Specialist

Benefits:

• Gym Access
• Dental insurance
• Health insurance

We're Hiring!+ The Regulatory Affairs Specialist develops technical label copy for corporate brand products, provides information to the business on regulatory matters and manages issues pertaining to labeling and advertising. RESPONSIBILITIES & DUTIES:

• Develops label copy, evaluates packaging and product formulations to ensure the correct labeling of new and existing products against the appropriate regulations, guidelines, internal labeling standards & policies.
• Reviews and approves artwork circulations and remains current on all labeling standards & policies
• Reviews advertising to ensure compliance with appropriate regulations and internal policies
• Delivers against key milestones to help support on-time delivery for all projects within BU
• Reviews preliminary formulations/concepts to help provide direction on potential or requested claims for new products
• Ensures that appropriate supporting analysis and documentation is in place to validate/support claims
• Resolves regulatory issues raised internally, or by government agencies. Initiate corrective action as required
• Provides support to the Quality compliance team by review of new legislation or proposed legislative changes and provides perspective on the corporate position and impact to the business
• Assists with the development of internal labeling standards, policies and guidelines
• Completes and submits applications for required licenses, Drug Identification Number (DIN), Natural Products Number (NPN) certificates, etc.
• Provides regulatory updates and impact to products and labeling to BU. Provides compliance support to BU as needed
• Completion and analysis of all regulatory applications with the Food & Drug Administration (FDA) and Health Canada
• Prepares and distributes Material Safety Data Sheets (MSDS) for customers
• Participates in approved/recognized regulatory body meetings within Canada and the U.S. with the associations that the Company is affiliated with
• Supports Quality Assurance, Research & Development, and Sales Departments with interpreting regulations related to Regulatory compliance
• Assessing all complaints and Handling, Evaluating and Reporting of Adverse Drug Reactions complaints
• Generate Annual Safety Reports for Apollo’s OTC products from Solicited and Unsolicited study, literature and regulatory databases.
• Manage Apollo’s Pharmacovigilance (PV) activities.
• Perform other duties as assigned

Requirements

• Minimum 5 years of experience in Regulatory Affairs, preferably within the cosmetics, personal care, or OTC/healthcare product industries.
• Post-secondary education required;
• Strong knowledge of the Canadian Food and Drugs Act and Regulations, including Consumer Packaging and Labelling Regulations and other applicable Health Canada requirements.
• Proven ability to interpret and apply regulatory guidelines to ensure product compliance.
• Demonstrated understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within a regulated manufacturing environment.