Regulatory Affairs Specialist

3 days ago


Toronto, Ontario, Canada Pyramid Consulting, Inc Full time

As a Regulatory Affairs Specialist with Pyramid Consulting, Inc., you will play a critical role in ensuring the compliance of our client's products with regulatory requirements.

About the Job

This is a 12+ months contract opportunity with long-term potential and is located in Toronto, ON (Hybrid). The ideal candidate will have a strong understanding of CMC dossier development and maintenance, as well as experience working with regulatory authorities.

Key Responsibilities
  • Develop and maintain CMC dossiers for commercial product submissions
  • Ensure compliance with regulatory requirements, including GMP and Health Authority regulations
  • Maintain the site's Drug Establishment License
  • Coordinate change control activities, including supplier change notifications
  • Provide regulatory expertise to site projects and evaluate the potential regulatory impact of change controls
Requirements

We are seeking a highly skilled Regulatory Affairs Specialist with at least 3-5 years of experience in the pharmaceutical/biologics industry. A bachelor's degree in a science/health field is required, and an advanced degree is preferred.

Skills and Qualifications
  • Strong understanding of CMC dossier development and maintenance
  • Experience working with regulatory authorities
  • Excellent problem-solving skills and ability to prioritize tasks
  • Ability to work effectively in a team environment
Salary and Benefits

The estimated salary for this position is $120,000-$150,000 per year, depending on experience. Additionally, we offer a comprehensive benefits package, including health insurance, 401(k) plan, and paid sick leave.



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