Senior Regulatory Affairs Consultant

Job summary

Review CMC regulatory documentation and provide strategic expertise, while drafting and updating SOPs based on Health Canada guidance and regulatory changes. Support the client’s CMC team in preparing and finalizing CTD Module 3 documentation, and provide additional short-term regulatory support as needed.

Job details

Title: CMC Regulatory Consultant / Senior Consultant Location: Remote (Canada) Duration: 6 months Capacity: 150 hours per month Company Overview Apsida Life Science is currently partnering with a specialised clinical trial support organisation that provides decentralised clinical trial services, home healthcare, and nursing support directly to patients participating in medical research studies. Responsibilities: CMC Expertise & Document Review: Review Chemistry, Manufacturing, and Controls (CMC) regulatory documentation, providing high-level subject matter expertise and strategic feedback. SOP Management: Lead and support the drafting, thorough review, and updating of internal SOPs to ensure compliance with updated industry standards. Regulatory Intelligence & Gap Analysis: Systematically review new and updated Health Canada guidance documents, assess potential impacts on existing operational SOPs, and recommend necessary revisions. Module 3 Documentation Support: Partner alongside the client’s existing CMC team to prepare, review, and finalize Module 3 (Quality) documentation for regulatory submissions. Ad Hoc Regulatory Support: Provide flexible, high-quality support on additional short-term or ad hoc CMC regulatory tasks as business needs arise. Qualifications: CMC Experience: Significant hands-on regulatory experience in Chemistry, Manufacturing, and Controls (CMC). Canadian Regulatory Expertise: Strong in-depth knowledge of Health Canada regulatory requirements, policies, and guidance frameworks. SOP Development: Proven track record of authoring, reviewing, and updating SOPs in response to changing regulatory landscapes. Module 3 Proficiency: Demonstrated direct experience working with CTD Module 3 documentation. Autonomy & Flexibility: Self-starter capable of working independently with minimal supervision while providing adaptable, short-term support. If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science: Sweetness.zono@apsida.com www.apsida.co.uk +44 (0) 744 134 2281 www.apsida.co.uk Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process

What you’ll do

Review CMC regulatory documentation and provide strategic expertise, while drafting and updating SOPs based on Health Canada guidance and regulatory changes. Support the client’s CMC team in preparing and finalizing CTD Module 3 documentation, and provide additional short-term regulatory support as needed.

Requirements

Requires significant hands-on CMC regulatory experience, in-depth knowledge of Health Canada requirements, and a proven record of developing and updating SOPs. Candidates must have direct CTD Module 3 experience and be able to work independently with minimal supervision.

Listed skills

• Documentation · Preferred
• Consultant · Preferred
• Health · Preferred
• Client · Preferred
• Recruitment · Preferred
• SOP · Preferred
• analysis · Preferred
• Capable of working independently · Preferred
• Compliance · Preferred
• Dedicated · Preferred
• Development · Preferred
• Flexible · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• CMC Regulatory Affairs
• Health Canada Regulatory Requirements
• Regulatory Documentation Review
• SOP Development
• Regulatory Intelligence
• Gap Analysis
• CTD Module 3 Documentation
• Quality Documentation
• Regulatory Submissions
• Strategic Regulatory Feedback
• Independent Work

Job areas

• Healthcare
• Science & Research
• Consulting

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