Regulatory Strategist - CMC at ClinChoice

Markham, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, CMC, Regulatory Submissions, U.S. FDA, Health Canada, Change Management, Compliance, Analytical Skills, Problem-Solving, Communication, Cross-Functional Collaboration, Attention to Detail, Quality Focus, DMF Assessments, Post-Approval Activities, Global Regulatory Strategies

Industry

Pharmaceutical Manufacturing

Description

Location: Remote in Canada Schedule: Permanent- FTE ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a CMC Strategist with REMOTE option in Canada on a permanent basis. Position Summary 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. Key Responsibilities Regulatory Strategy & Planning • 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. Regulatory Submissions (U.S. FDA & Health Canada) • 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. Post-Approval Activities • Manage post-approval submissions to US FDA, including: o Major and Moderate CMC amendments o Administrative amendments o DMF amendments o 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. Change Control & Compliance • 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 Qualifications • 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. Preferred Skills & Competencies • 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. Who will you be working for? 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 over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Regulatory CMC. The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following): 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 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 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.

Responsibilities

The Regulatory Strategist - CMC will develop and execute regulatory strategies for new product development and lifecycle management, as well as prepare and manage regulatory submissions to U.S. FDA and Health Canada. The role also involves managing post-approval activities and ensuring compliance with regulatory guidelines.