Job Description
Responsibilities
• Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable).
• Train on the company's ERV/Veeva Vault system and manage HAQ responses within the ERV system
• Coordinate HAQ response development across internal technical teams.
• Track HAQs, response timelines, commitments, and dependencies to ensure on-time, high-quality submissions.
• Interpret and apply global/regional CMC regulatory guidelines and regulations.
• Review SME-drafted HAQ responses for regulatory appropriateness, clarity, consistency and alignment with regional CMC expectations.
• Extract and summarize scientific information from development reports and identify details required for regulatory submissions.
• Organize data to support the group's function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).
• Advise SMEs on how to frame technical data and rationales to meet Health Authority expectations.
• Serve as the CMC regulatory point of contact for global Health Authority Questions (e.g. FDA, EMA, MHRA, PDMA, other regions as applicable).
• Train on the company's ERV/Veeva Vault system and manage HAQ responses within the ERV system
• Coordinate HAQ response development across internal technical teams.
• Track HAQs, response timelines, commitments, and dependencies to ensure on-time, high-quality submissions.
• Interpret and apply global/regional CMC regulatory guidelines and regulations.
• Review SME-drafted HAQ responses for regulatory appropriateness, clarity, consistency and alignment with regional CMC expectations.
• Extract and summarize scientific information from development reports and identify details required for regulatory submissions.
• Organize data to support the group's function with answering questions, information request from regulatory agencies such as the FDA, Health Canada or EMEA (including relevant country specific authorities).
• Advise SMEs on how to frame technical data and rationales to meet Health Authority expectations.
💡 Quick Summary
Seeking a career-building opportunity? The CMC Regulatory Consultant position is now open for candidates interested in the Operations Executive Jobs sector. This role in Toronto offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Operations Executive Jobs is a plus.
