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Regulatory Affairs Coordinator 12 Month Contract
3 weeks ago
**STATUS**:*12 MONTH CONTRACT**
**INDUSTRY**: Pharmaceutical
**LOCATION**: Kirkland, Quebec
**WORK HOURS**: 37.50 hours a week - Monday to Friday
**WORK MODEL**: Hybrid work model.
- Minimum of two (2) to three (3) days a week in the office (Kirkland, QC)
**VERY IMPORTANT**
- THIS IS NOT A REMOTE POSITION;
- CANDIDATES MUST LIVE IN THE GREATER MONTREAL AREA AS THEY MUST BE PHYSICALLY IN THE OFFICE FOR A MINIMUM OF TWO (2) TO THREE (3) DAYS A WEEK WHICH IS LOCATED IN KIRKLAND, QUEBEC;
- OUR CLIENT'S COMPANY POLICY REQUIRES THAT ALL EMPLOYEES BE FULLY VACCINATED;
Coordinator, Regulatory Affairs
**Role Purpose**: Coordinates and executes a wide variety of activities in support of the Regulatory Affairs Department and corporate business objectives.
**Core Responsibilities**:
- Provides comprehensive resource support to the Compliance & Systems Associate Director and regulatory affairs professionals in the fulfillment of corporate business objectives.
- Systems and Records Management: Tracks and enters product-specific submission data in records management systems to ensure availability of up-to-date information.
- Regulatory Submissions: Assists in the timely coordination of all activities related to electronic submission production and related tasks to meet Health Canada’s Submission Management requirements for regulatory approval.
- Technical Operations: Assists the Compliance & Systems team in the preparation of Canadian electronic submissions as well as in Investigator Initiative Package review assistance, as applicable.
**General Qualifications**:
- Extensive computer knowledge (e.g. Microsoft Suite, eCTD Publisher, Acrobat Adobe, Teams)
- Detail-oriented and ability to work simultaneously on multiple projects
- Strong interpersonal skills and ability to work in a team environment
- Strong organizational skills
- Effective verbal and written communication skills
- Excellent English communication skills is a must
- Good French communication skills
- Pharmaceutical industry experience, ideally in Regulatory Affairs, is an asset.
**STATUS**:*12 MONTH CONTRACT**
**INDUSTRY**: Pharmaceutical
**LOCATION**: Kirkland, Quebec
**WORK HOURS**: 37.50 hours a week - Monday to Friday
**WORK MODEL**: Hybrid work model.
- Minimum of two (2) to three (3) days a week in the office (Kirkland, QC)
**VERY IMPORTANT**
- THIS IS NOT A REMOTE POSITION;
- CANDIDATES MUST LIVE IN THE GREATER MONTREAL AREA AS THEY MUST BE PHYSICALLY IN THE OFFICE FOR A MINIMUM OF TWO (2) TO THREE (3) DAYS A WEEK WHICH IS LOCATED IN KIRKLAND, QUEBEC;
- OUR CLIENT'S COMPANY POLICY REQUIRES THAT ALL EMPLOYEES BE FULLY VACCINATED;
