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 versatile, 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: [email protected] www.apsida.co.uk

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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

📌 Senior Regulatory Affairs Consultant (Canada)
🏢 Apsida Life Science
📍 Canada