Position Summary We are seeking a Regulatory Strategist – CMC to support global regulatory strategy and execution across the product lifecycle. This 12‑month contract, renewable, is remote (Canada). The 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.Key ResponsibilitiesDevelop 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 U.S. 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 U.S. FDA, including major and moderate CMC amendments, administrative amendments, DMF amendments, and 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.Required QualificationsBachelor’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.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.About ClinChoice ClinChoice is a global full‑service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high‑quality delivery and results across all our services with more than 4,000 professionals in more than 20 countries.Equal Opportunity Employer ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier‑free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians with Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647) 724‑5709 x 301.We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with the Federal Personal Information Protection and Electronic Documents Act ('PIPEDA'), personal information is collected under the authority of the Act and will only be used for candidate selection.#J-18808-Ljbffr