CMC Regulatory Consultant

Job summary

Review CMC regulatory documentation and provide hands-on support with Module 3 materials, including identifying gaps and supporting submission readiness. Draft, review, and update SOPs in response to Health Canada guidance, collaborate with the client's CMC colleague, and assist with additional regulatory tasks.

Job details

Apsida Life Science is partnering with a global CRO company to present the following role: Canadian CMC Regulatory Affairs Consultant or Senior Consultant Remote 6 months Full time Our client is seeking an experienced Canadian CMC Regulatory Affairs Consultant or Senior Consultant to provide short-term support with Chemistry, Manufacturing and Controls (CMC) regulatory activities. The consultant will review CMC regulatory documentation, support the preparation and updating of Standard Operating Procedures (SOPs), and assess the impact of new Health Canada guidance on existing procedures. The role will also involve hands-on support with Module 3 CMC documentation, working alongside the client's existing CMC colleague, as well as assisting with additional regulatory activities as required. The ideal candidate will have strong CMC regulatory expertise, a sound understanding of Canadian regulatory requirements, and the ability to provide independent, flexible support within a short-term engagement. Key Responsibilities Review CMC regulatory documentation and provide subject matter expertise to support regulatory compliance and submission readiness. Support the drafting, review, revision, and updating of SOPs relating to CMC regulatory activities. Monitor new and updated Health Canada guidance and assess its potential impact on existing SOPs, procedures, and regulatory documentation. Recommend and support necessary SOP updates to ensure alignment with applicable Canadian regulatory requirements. Provide hands-on support with Module 3 CMC documentation, including reviewing and updating relevant sections as required. Collaborate with the client's existing CMC colleague to address documentation gaps, regulatory requirements, and ongoing CMC activities. Support additional ad hoc CMC regulatory tasks and documentation reviews as required throughout the engagement. Required Experience and Qualifications Strong experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. Good knowledge of Canadian regulatory requirements and applicable Health Canada guidance. Hands-on experience reviewing, drafting, or updating SOPs in response to regulatory requirements or changes in Health Authority guidance. Practical experience reviewing, preparing, or updating Module 3 CMC documentation for regulatory submissions. Understanding of CMC regulatory documentation requirements and their application to pharmaceutical product submissions. Ability to independently review regulatory documentation, identify gaps, and recommend appropriate actions. Strong written communication, analytical, and document-review skills. Ability to work collaboratively with existing CMC personnel while managing assigned tasks independently. Availability to provide flexible, short-term consulting support. If you are interested in learning more, please reach out to Mufaro Mpofu at Apsida Life Science: mufaro.mpofu@apsida.com 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 hands-on support with Module 3 materials, including identifying gaps and supporting submission readiness. Draft, review, and update SOPs in response to Health Canada guidance, collaborate with the client's CMC colleague, and assist with additional regulatory tasks.

Requirements

Candidates should have strong pharmaceutical or biotechnology CMC Regulatory Affairs experience, knowledge of Canadian requirements and Health Canada guidance, and practical experience with SOPs and Module 3 CMC documentation. They must be able to assess documentation independently, communicate effectively, collaborate with existing CMC personnel, and provide flexible short-term support.

Listed skills

• Regulatory Compliance · Preferred
• written communication · Preferred
• Cross-Functional Collaboration · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• CMC Regulatory Affairs
• Canadian Regulatory Requirements
• Health Canada Guidance
• SOP Drafting and Review
• Module 3 CMC Documentation
• Regulatory Documentation Review
• Regulatory Compliance
• Submission Readiness
• Regulatory Impact Assessment
• Gap Analysis
• Document Updating
• Written Communication
• Analytical Skills
• Independent Work
• Cross-Functional Collaboration

Job areas

• Healthcare
• Science & Research
• Consulting

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