Join Amaris Consulting as a Regulatory Writer focusing on global submission strategies to optimize your career in a hybrid working environment. Your role will ensure high-quality documentation aligns with regulatory standards.

This permanent Senior Medical Writer position is essential in developing regulatory content and managing the documentation for pharmaceuticals and medical devices. Your responsibilities will include coordinating preparation efforts, reviewing documentation for compliance, and facilitating communication with stakeholders. You will also mentor junior writers and contribute to continuous improvement initiatives in regulatory content processes.

Key Responsibilities:
• Lead development of submission strategies for global regulatory bodies
• Coordinate clinical dossiers and safety document preparation




• Drive content quality and compliance across documents
• Collaborate to resolve issues affecting submission timelines
• Stay current with evolving regulatory guidelines

Requirements:
• Bachelor’s degree or higher in Life Sciences
• 5+ years experience in regulatory writing
• Extensive knowledge of drug/device development regulations
• Expertise in clinical and safety documentation
• Solid communication and project management skills

Your leadership will help drive regulatory excellence and successful submissions at Amaris Consulting.
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📌 Regulatory Writer - Global Submissions Expert (Ontario)
🏢 AMARIS GROUP
📍 Ontario