Regulatory Affairs Associate

1 week ago


Scarborough, Canada United Pharma Full time

Additional Responsibilities:

- Support International team by coordinating, generating or requesting various documents to aid in product registrations and importations for regions including Latin America, Middle East and Europe.
- Support International and Canadian team on new product research and development by the evaluation of formulations and labels for compliance
- Demonstrate an ability to monitor, inform, suggest, recommend and apply, after necessary approval from manager, actions necessary to meet and maintain regulatory (food and drug) compliance
- Coordinate Canadian submissions and site license renewal with Natural and Non-Prescription Health Products Directorate
- Review and update internal Standard Operating Procedures, as needed
- Other role related duties as assigned

**Core Competencies**:

- BSc in Pharmacy, Pharmacology, Chemistry, Biological Sciences, or equivalent, preferred
- Postgraduate Certificate in Pharmaceutical Regulatory Affairs and Quality Assurance is an asset
- Minimum 1-2 years of regulatory affairs experience preferably within a consumer packaged goods regulated environment (direct dealings with FDA, NNHPD)
- Knowledge of Canadian Natural and Non-Prescription Health Products Regulations, including Product License Applications
- Key skills include: Results-driven, accountable/own tasks, detail oriented, effective communicator and able to problem-solve with multiple priorities at one time
- Proactive and able to manage change in an extremely fast paced, energetic work environment
- Proficient in the use of MS Office Suite
- Solid knowledge of research tools i.e. PubMed

**Job Types**: Full-time, Part-time

Pay: $23.00-$30.00 per hour

Schedule:

- Day shift
- Monday to Friday

Ability to commute/relocate:

- Scarborough, ON: reliably commute or plan to relocate before starting work (preferred)

Work Location: One location



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