Regulatory Affairs Specialist

Benefits:Gym AccessDental insuranceHealth insuranceWe'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 & policiesReviews advertising to ensure compliance with appropriate regulations and internal policiesDelivers against key milestones to help support on-time delivery for all projects within BUReviews preliminary formulations/concepts to help provide direction on potential or requested claims for new productsEnsures 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 businessAssists with the development of internal labeling standards, policies and guidelinesCompletes 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 complaintsGenerate 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 assignedRequirementsMinimum 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.