Regulatory Affairs Specialist II
4 hours ago
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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Regulatory Affairs Specialist II
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Toronto, Ontario, C6A, Ontario, Canada Pyramid Consulting, Inc Full timeImmediate need for a talented Regulatory Affairs Specialist II . This is a 12+ Months Contract opportunity with long-term potential and is located in Toronto, ON (Hybrid). Please review the job description below and contact me ASAP if you are interested.Job ID:24-53180Pay Range: $45 - $50/hour. Employee benefits include, but are not limited to, health...
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
2 months ago
Toronto, Canada McCain Foods Full time**Position Title**: Regulatory Affairs Specialist **Position Type**: Regular - Full-Time **Position Location**: Toronto HQ ; Florenceville-Bristol, New Brunswick, Canada **Grade**: Grade 04 **Requisition ID**: 32400 **Position Summary**: The Regulatory Affairs Specialist is responsible for product composition and label regulatory compliance for finished...
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Regulatory Affairs Specialist
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