Regulatory Affairs Specialist

3 days ago

Toronto, Canada Apollo Health And Beauty Care Full time

**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
- Provides regulatory updates and impact to products and labeling to BU. Provides compliance support to BU as needed
- 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.
- Demonstrated understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) within a regulated manufacturing environment.

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