Key Responsibilities:

• Lead CMC regulatory projects, including site transfer registrations, and report progress to business stakeholders
• Develop regulatory strategies for CMC aspects of site transfers, new marketing authorization applications (MAAs), and product development initiatives
• Conduct due diligence and compliance gap assessments, identifying regulatory risks and opportunities for assigned product dossiers
• Review and evaluate technical documentation, including process validation, analytical methods, specifications, and stability data
• Provide regulatory input and support for Change Controls, defining CMC strategies and actions
• Prepare, coordinate, and maintain Module 3 documentation and other CMC-related submissions (variations, reformulations, post-approval changes)
• Ensure submission timelines are met to maintain continuity of product supply and market compliance
• Collaborate with internal teams and health authorities to resolve CMC-related queries and regulatory issues
• Support MDR-related changes, product quality reviews, and other lifecycle management activities
• Monitor and interpret changes in global and regional regulatory requirements, proactively managing their impact
• Contribute to internal process improvement, development of best practices, and regulatory data integrity

Experience and Qualifications:

• University degree in Pharmacy, Chemistry, or Life Sciences (or equivalent scientific background)
• 5+ years of experience in CMC Regulatory Affairs or R&D within the pharmaceutical or healthcare industry
• Strong technical background with deep understanding of ICH Q guidelines and global quality/regulatory standards
• Proven experience with OTC medicines and various dosage forms (semi-solids, tablets, effervescent tablets, nasal preparations)
• Expertise in technical product transfers and analytical method transfers
• Demonstrated experience authoring Module 3 and managing post-approval variations
• Solid understanding of regulatory strategy and cross-functional project management
• Excellent analytical, organizational, and communication skills
• Fluent English (spoken and written); knowledge of French is an asset

Personal Profile:

• Self-motivated and adaptable to changing priorities
• Strong attention to detail and ability to handle multiple complex projects simultaneously
• Effective team player with excellent collaboration skills across departments and external partners
• High level of accountability and drive to meet regulatory and business objectives
• Passion for healthcare innovation and product quality