Regulatory Affairs Compliance Associate

Location: Montreal, #LI-Hybrid
13 month contract
About the role:
We are looking for an organized, collaborative and passionate Regulatory Affairs professional who is driven to help us deliver our innovative treatments to patients. As a compliance lead, you will report directly to the head of Regulatory Affairs and be responsible for ensuring the department’s compliance to internal and external processes and procedures, and suggesting improvements to processes. You will also be responsible for creating and driving strategic initiatives, and collaborating in a dynamic environment with internal and external stakeholders.
Key Responsibilities:
• Performs periodic audits against department procedures and best practices and prepares reports on findings with recommendations.
• Ensures gap assessments and periodic reviews of SOPs are tracked and completed in a timely manner
• Prepares and maintains various departmental and Health Canada trackers
• Ensures required PSURs are on file and submitted as required.
• Maintains projections for submissions fees; requests opening of Purchase Orders and processes payment of invoices for the department
• Assists the Head of RA with special projects as required.

Essential Requirements:
• CEGEP DEC or equivalent
• 3-5 years of work experience
Desirable Requirements:
• Experience in the Pharmaceutical industry
• Bilingual: English and French an asset.
Novartis
Our purpose is to reimagine medicine to improve and extend people’s life and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network