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Regulatory Affairs Associate
2 months ago
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.
- 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.
- 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.
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.