Regulatory CMC Operations Specialist - eCTD & Compliance

Why This Role Matters
Chemistry, Manufacturing, and Controls (CMC) submissions form the backbone of regulatory approvals and lifecycle maintenance for pharmaceutical products. Accurate, compliant, and timely CMC documentation ensures uninterrupted clinical development, successful regulatory filings, and continued product availability for patients.
At Novartis, Regulatory CMC Operations professionals play a vital role in coordinating submission activities, maintaining eCTD readiness, and ensuring regulatory data integrity across global markets. This role supports structured regulatory processes while leveraging digital tools, data systems, and AI-enabled technologies to enhance operational excellence.

Job Description
We are seeking a detail-driven and process-oriented Regulatory CMC Operations Specialist to support compliance, submission coordination, and regulatory data stewardship activities. The selected candidate will be responsible for ensuring that CMC documentation is accurate, eCTD-compliant, and delivered on time to support global regulatory filings.
This role is ideal for a regulatory professional who values structured workflows, thrives in cross-functional collaboration, and is interested in strengthening expertise in CMC operations, digital systems, and regulatory project coordination.

Key Features of the Role
• Hands-on exposure to CMC submission coordination and compliance checks
• Involvement in eCTD documentation readiness and publishing support
• Opportunity to act as data steward within RIMS/DMS platforms
• Collaboration with global cross-functional regulatory project teams
• Exposure to AI-enabled tools and digital transformation initiatives
• Participation in KPI reporting and operational analytics

Responsibilities
• Perform compliance and operational activities including CMC submission QC checks, document format verification, and IND annual report writing
• Serve as CMC contact for assigned countries and manage regulatory database entries and compliance reports
• Create CMC submission documentation including folder structures, metadata, and RA request forms
• Act as data steward in Regulatory Information Management Systems (RIMS) and Documentation Management Systems (DMS)
• Ensure documentation is eCTD compliant, including correct file naming conventions and PDF property validation
• Coordinate and prepare CMC submissions for delivery to Regulatory Affairs Publishing teams
• Collate ancillary document requirements from databases and internal tracking systems
• Track submission milestones and maintain data/KPIs for RA CMC reporting
• Perform super-user responsibilities for RA CMC documentation systems, including account requests and ticket management
• Acquire and maintain GMP Certificates and Manufacturing Authorizations within DMS
• Support end-to-end submission coordination across multiple projects
• Manage multiple priorities while maintaining regulatory compliance and structured documentation practices

Required Qualifications

Educational Requirements:
• Master’s in Pharmacy with minimum 2 years of regulatory CMC experience (excluding internship)
OR
• Other Scientific Master’s Degree with minimum 3 years of regulatory CMC experience (excluding internship)

Experience and Skills:
• Experience in Regulatory CMC operations, compliance, and submission coordination
• Familiarity with pharmaceutical documentation systems and Regulatory Information Management Systems (RIMS)
• Understanding of data standards and data management tools
• Strong planning and organizational skills
• Proven ability to work with global cross-functional project teams
• Excellent written and verbal communication skills
• Demonstrated multitasking capability and ability to manage competing priorities
• High level of digital and data fluency
• Familiarity with AI-enabled tools and emerging IT technologies
• Strong computer literacy and data-processing proficiency

Salary Insights
Compensation is competitive and aligned with industry benchmarks for regulatory CMC operations professionals. The final salary package will depend on experience level, digital system expertise, and global regulatory exposure. Benefits typically include performance-based incentives, hybrid work flexibility, and structured career progression opportunities.

Company Overview
Novartis is a global healthcare leader committed to reimagining medicine to improve and extend people’s lives. The organization fosters a culture of innovation, collaboration, and inclusion while leveraging digital transformation to enhance regulatory and operational excellence.
Novartis is committed to diversity and inclusion and provides equal opportunities to all qualified individuals. The company also ensures reasonable accommodations for candidates with disabilities throughout the recruitment process.

FAQs

• Is prior CMC submission experience mandatory?
Yes, prior hands-on experience in Regulatory CMC operations is required as per the eligibility criteria.

• Does this role involve interaction with publishing teams?
Yes, the role includes coordinating and preparing submissions for delivery to Regulatory Affairs Publishing.

• Are digital skills important for this position?
Yes, strong digital fluency and familiarity with AI-enabled tools are key components of the role.

• Does the position involve global collaboration?
Yes, candidates will work closely with global cross-functional teams.

Application Tips
• Highlight hands-on experience with eCTD compliance and submission QC checks
• Mention experience with RIMS, DMS, and regulatory databases
• Emphasize structured project coordination and multitasking ability
• Showcase digital literacy and familiarity with AI or emerging technologies
• Provide examples of cross-functional collaboration in regulatory projects