Regulatory Affairs Specialist

7 days ago

Toronto, Ontario, Canada Apollo Health And Beauty Care Full time $90,000 - $120,000 per year

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.
 

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