Regulatory Affairs CMC

Hiring: Regulatory CMC – Site & Regional Roles

We are hiring experienced Regulatory CMC professionals to support both Site-level change management and regional submission activities across a diverse portfolio including small molecules, biologics, vaccines, and plasma-derived therapies.

This role will work closely with Global Regulatory CMC teams, manufacturing sites, and local affiliates to ensure efficient, compliant, and streamlined post-approval lifecycle management.

🎯 Role Objective

The role is responsible for managing post-approval change control and regulatory submissions by connecting site execution with regional delivery, ensuring alignment with global strategies and country-specific requirements.

It focuses on driving efficiency, consistency, and compliance through risk-based approaches, standardized processes, and regional coordination.

🔑 Key Responsibilities

• Manage post-approval change control activities at site level, including evaluation of change records and preparation of regulatory submissions
• Apply science- and risk-based approaches (aligned with ICH guidelines such as ICH Q12) to assess and implement changes
• Act as a key interface between Global Regulatory CMC teams, manufacturing sites, and regional affiliates
• Translate global CMC strategies into regional submission plans, ensuring alignment with local regulatory requirements
• Prepare, review, and coordinate regulatory dossier submissions across multiple markets
• Collaborate with external manufacturing sites and suppliers to align on change control and regulatory expectations
• Drive standardization and harmonization of processes across sites and regions to improve efficiency and reduce duplication
• Support the use of digital tools and automation to enhance predictability and consistency in regulatory activities
• Identify process gaps and contribute to continuous improvement initiatives
• Monitor submission timelines, approvals, and regulatory milestones across regions

🎓 Qualifications & Experience

• Bachelor’s or master’s degree in pharmacy, Life Sciences, Chemistry, or related field
• 6–15 years of experience in Regulatory Affairs CMC
• Experience in post-approval change management and/or regional regulatory submissions
• Exposure to global regulatory requirements (US, EU, APAC, LATAM, GCC, etc.)
• Experience working with multiple product modalities (small molecules, biologics, vaccines, plasma-derived products)
• Familiarity with ICH guidelines (especially ICH Q12)

💡 Key Skills

• Regulatory CMC & lifecycle management
• Change control & post-approval submissions
• Regional submission coordination
• Stakeholder & affiliate management
• Process improvement & standardization
• Strong communication and collaboration skills