Regulatory Strategist Consultant - CMC

ClinChoice•Markham, ON

8d•$1 - $2•Hybrid

About The Position

ClinChoice is searching for a CMC Strategist Consultant with HYBRID option in CANADA for 12 months CONTRACT and renewable, to join one of our major consumer products clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This role will be responsible for developing and implementing CMC regulatory strategies, preparing and reviewing high-quality regulatory submissions, and supporting post-approval activities for U.S. FDA and Health Canada. The ideal candidate brings strong technical CMC knowledge, hands-on submission experience, and the ability to partner cross-functionally with CMC, Quality, and Manufacturing teams.

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline (advanced degree preferred).
3+ years of experience in CMC regulatory affairs within pharmaceutical, biotech, or CDMO environments.
Hands-on experience with U.S. FDA and Health Canada CMC submissions across the product lifecycle.
Strong working knowledge of ICH guidelines, FDA regulations, and Health Canada requirements.
Experience compiling and reviewing Modules 1–3 and working with Drug Master Files (DMFs).
Proven ability to manage multiple submissions and timelines in a fast-paced environment.

Nice To Haves

Strong analytical and problem-solving skills.
Excellent written and verbal communication abilities.
Ability to work cross-functionally and influence stakeholders.
High attention to detail with a quality- and compliance-focused mindset.
Experience with global regulatory strategies beyond North America is a plus.

Responsibilities

Develop and execute CMC regulatory strategies for new product development and product lifecycle management.
Support regulatory strategy planning and act as a key contributor to dossier planning for global submissions.
Provide regulatory input on CMC development activities, change management, and post-approval strategies.
Support preparation and submission of CMC regulatory documents for new product filings to US FDA and Health Canada.
Compile, review, and manage Modules 1, 2, and 3 of U.S. regulatory dossiers.
Review CMC documentation and perform DMF assessments, including coordination with DMF holders as needed.
Manage post-approval submissions to US FDA, including: Major and Moderate CMC amendments, Administrative amendments, DMF amendments, Annual Reports.
Lead and coordinate timely responses to FDA Information Requests (IRs) and Complete Response Letters (CRLs).
Support post-approval submissions to Health Canada, including compilation and submission of Annual Notifications and Supplements.
Assess and manage Global Change Controls (GCCs) to determine regulatory impact and required filings.
Support preparation and review of Annual Product Reports (APRs).
Ensure compliance with applicable regulatory guidelines, policies, and global CMC requirements.