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Regulatory Affairs Expert

3 weeks ago

Toronto, Canada Raise Full time
Job Description:

In this pivotal role as a Regulatory Affairs Specialist II (Clinical), you will play a crucial part in ensuring the regulatory compliance of products at our client's site(s). The ideal candidate will possess a strong understanding of cGMP documents, batch release processes, and Drug Establishment Licenses.

Responsibilities:
  • Regulatory Compliance: Ensure product regulatory compliance by following submission and approval procedures.
  • CMC Documentation Management: Maintain CMC dossiers aligned with manufacturing and control procedures on site(s) and approved by Health Authorities.
  • cGMP Document Review: Review Master Specification documents and other relevant documents to ensure compliance.
  • Change Control: Implement and maintain effective change control processes.
  • Regulatory Expertise: Provide regulatory expertise to site projects and evaluate potential regulatory impacts.
Requirements:
  • Education: Minimum of a Bachelor's Degree; advanced degree preferred.
  • Experience: At least 3-5 years of Regulatory Affairs CMC experience or combination of experience in Quality roles.
  • Skills: Strong verbal and written communication skills, self-motivation, attention to detail, and organizational ability.
About the Company:

We are Raise, a leading provider of innovative solutions. Our team is passionate about delivering exceptional results and making a difference in the industry.