Benefits:
Gym Access
Dental insurance
Health insurance
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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.
