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Regulatory Affairs Associate

2 months ago


Boucherville, Quebec, Canada Sandoz Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Sandoz. As an Associate, Regulatory Affairs, Operations, you will play a critical role in ensuring the compliance of our products with regulatory requirements.

Key Responsibilities
  • Regulatory Review and Compliance: Conduct thorough reviews of artwork and labeling to ensure compliance with Health Canada guidelines and regulations.
  • Labeling and Packaging Management: Establish and maintain department standards for packaging and labeling documents, and coordinate and track Safety Label Changes to ensure compliance with global SOP timelines and process.
  • Project Management: Manage multiple projects simultaneously, prioritizing tasks and ensuring timely completion of regulatory submissions.
  • Collaboration and Communication: Work closely with cross-functional teams, including Regulatory Associates and RCC teams, to ensure seamless communication and collaboration.
  • Regulatory Knowledge and Expertise: Stay up-to-date with changes in guidelines and regulations, and apply this knowledge to ensure compliance and accuracy in regulatory submissions.
Requirements
  • Education: Bachelor's degree in Sciences, Biochemistry, Chemistry, Microbiology, Pharmacology, or Pharmacy.
  • Experience: 2-3 years of experience in Regulatory Affairs or Quality.
  • Language Skills: Fluency in oral and written French is mandatory, and proficiency in English is required for regular communication with customers, partners, and/or colleagues.
  • Skills and Abilities: Ability to manage priorities, work autonomously, and collaborate with teams; detail-oriented and organized with excellent communication skills.
What We Offer
  • Competitive Compensation and Benefits: A minimum of three weeks' vacation, paid time off, and a comprehensive benefits package.
  • Professional Development Opportunities: Career enhancement and development, including learning, training, and professional recognition opportunities.
  • Collaborative Work Environment: A dynamic and inclusive work environment with a diverse team of talented and ambitious colleagues.
About Sandoz

Sandoz is a leader in the global medicines industry, with a commitment to delivering affordable, quality medicines to patients every day. We are proud of our achievements and are driven by a passion to shape the future of healthcare.