Description
Role Overview
Reporting to the Senior Director, Regulatory Affairs & Pharmacovigilance, the Senior Specialist, Regulatory CMC manages Chemistry, Manufacturing and Controls (CMC) change controls and the resulting regulatory work for pharmaceutical products in Canada and the United States. The role assesses changes, determines the appropriate reporting pathway and implementation requirements, prepares post-approval submissions and notifications, and coordinates documentation and follow-up with internal teams and external partners. Working across a diverse product portfolio and with internal and external partners, the role manages multiple concurrent CMC changes and regulatory activities with varying timelines, dependencies, and supply considerations. This dedicated capacity supports compliant product lifecycle management and timely execution across the portfolio.
Key Responsibilities:Change Control Management and Regulatory Impact Assessment- Manage the regulatory assessment and execution of CMC change controls for Canadian and U.S. products, from initial review through implementation and closure
- Evaluate manufacturing, analytical, supplier, site, packaging, formulation and process changes against approved dossiers and applicable requirements; document the reporting category, supporting data, approval or notification needs, and implementation timing
- Independently assess routine and moderately complex CMC changes and recommend regulatory pathways, escalating novel, high-risk, or precedent-setting matters to regulatory leadership
- Coordinate with Quality Assurance and technical teams to resolve information gaps, track dependencies and confirm that changes are implemented and documented in accordance with regulatory requirements
- Manage multiple concurrent CMC changes and related submission activities, prioritizing work based on regulatory requirements, implementation timelines, supply impact, and business risk
Post Approval CMC Submissions and Lifecycle Management- Prepare, review and coordinate CMC submissions and maintenance activities arising from changes, including Canadian Level III notifications and relevant DEL or labeling updates, and U.S. Annual Reports and CBE-0/CBE-30 submissions, as applicable
- Review technical source documents and submission content for accuracy, consistency with approved dossiers and readiness for publishing and filing
- Track filing dates, health authority responses, regulatory commitments and implementation milestones; maintain complete and traceable submission records
Cross Functional Partner and Health Authority Coordination- Work with internal Regulatory Affairs, Quality Assurance, Technical Operations, Supply Chain and labeling teams, as well as CDMOs and other external partners, to obtain required technical documentation, resolve information gaps, align filing and implementation plans, and support continuity of supply
- Coordinate with regulatory operations or publishing resources on eCTD preparation, dispatch, confirmation and archival, and support responses to FDA and Health Canada questions
- Escalate significant regulatory risks, conflicting priorities or implementation issues to senior regulatory leadership with recommended next steps
Regulatory Strategy and Intelligence- Monitor and interpret evolving FDA and Health Canada CMC requirements and guidance; assess their potential impact on the Medexus portfolio and incorporate relevant changes into regulatory assessments and submission plans
- Contribute practical improvements to change-control workflows, tracking tools, templates and submission processes
- Evaluate regulatory options for CMC changes and recommend approaches that balance regulatory requirements, implementation timing, supply continuity, and compliance risk
Qualifications- Bachelor's degree in a relevant life science or related scientific discipline, such as chemistry, pharmaceutical sciences, biology, biochemistry or chemical engineering
- 3+ years of Regulatory Affairs experience in the pharmaceutical or biologics industry with meaningful experience in post-approval CMC activities
- Hands-on experience assessing post-approval CMC changes, including determining regulatory reporting requirements and implementation timing
- Experience preparing or coordinating post-approval CMC submissions, with exposure to FDA- and Health Canada-regulated products
- Working knowledge of Module 3 quality documentation, manufacturing processes, specifications, analytical methods, stability, validation and pharmaceutical quality systems
Additional Information:• Canada Compensation range: $100,000-$140,000
• Travel or other requirements: 10%
We recognize that experience comes in many forms. Even if your background or compensation expectations don't exactly align with all the qualifications or compensation range listed, we encourage you to apply. Your unique skills and experience may be a great fit for this role or other opportunities at Medexus.
Compensation
$100,000.00 - $140,000.00 per year
