Regulatory Affairs Specialist II

4 hours ago


Toronto, Canada Pyramid Consulting, Inc Full time
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team in Toronto, ON. As a key member of our regulatory affairs department, you will be responsible for ensuring the company's products comply with regulatory requirements.

Key Responsibilities:

  • Supports batch release by following submission and approval to ensure product regulatory compliance on site(s).
  • Ensures that CMC dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities.
  • Reviews cGMP documents such as Master Specification documents.
  • Maintains site's Drug Establishment License.
  • Change Control
  • Provides regulatory expertise to site projects.
  • Evaluates potential regulatory impact of site's change controls including supplier change notifications.
  • CMC Documentation management.
  • Writes CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submission (CMC portions of Module 1, Module 2.3 and Module 3).
  • Covers CMC writing performed by another entity (internal or external).
  • Optimizes content of CMC dossiers to facilitate management of future changes.
  • Prepares answers to questions from Health Authorities with contribution of site experts.
  • Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers) by writing corresponding CMC documents/dossiers and collecting GMP related documents from site(s).
  • Consolidates regulatory activities in a planning tool.


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