Coordonnateur des affaires règlementaires

The Regulatory Affairs Coordinator will provide project and administrative support and coordination for the Global Regulatory Affairs department.

He / she will assist in the management of regulatory documents to support product development and compliance. The ideal candidate is highly organized with a desire and ability for continuous learning, has good communication and computer skills and can adapt to changing priorities.

Responsabilities & Duties :

Document and archive management :

• Maintains and organizes regulatory documentation in a timely manner in accordance with departmental policies and practices.
• Responsible for access to the archive room in a controlled manner and the orderly storage and retrieval of files and materials are facilitated by an indexing system.
• Ensure that the movement of records and documents in and out of the archive is properly controlled and documented.
• Liaise with archive donors and depositors, both internal and external to the organization.
• Follows current archiving procedures as outlined in the SOPs; and applies any other policies to ensure that archiving is carried out in accordance with the requirements of the OECD consultative document "Establishment and Control of Archives Operating in Accordance with GLP Principles".

Database entry and reporting :

• Provides regulatory updates and status reports, including tracking of bid fees and other invoices.
• Enters key regulatory data into departmental databases and tracking tools.

Submission assistance :

Provides support for the planning, preparation and compilation of regulatory administrative submissions / documents to Canadian and international regulatory authorities.

This may include editing and formatting of selected regulatory documents.

Administrative duties :

• Assists regulatory managers at strategic meetings and follows up on meeting minutes.
• Organizes and coordinates departmental meetings and events.
• Acts as liaison between the regulatory team, business customers and partners to facilitate communication and follow-up.
• Organizes logistics and integration of new team members.
• Other administrative duties as required (including meeting planning, travel arrangements).

Skills, Knowledge & Abilities :

• Good analytical skills, strong attention to detail and a commitment to accuracy and depth.
• Demonstrate adaptability in situations involving change as well as the ability to act without having all the information.
• Ability to work simultaneously on multiple projects and under tight deadlines; ability to prioritize and follow standards and processes.
• Comfortable both working independently and interacting with various departments and people, as required. Demonstrate the ability to identify, initiate and complete tasks.
• Demonstrate good interpersonal skills that will enable him / her to function effectively in a fast-paced, people-oriented team environment.
• Knowledge of Canadian or international regulations and ability to retrieve information.
• Practical experience in coordinating and preparing regulatory documents.
• Demonstrated proficiency in the use of Microsoft (including Word, Excel and PowerPoint) and Adobe suites.
• Excellent communication skills (written and oral) in English and French
• Knowledge of the drug development process is an asset.
Il y a 17 jours