About You – experience, education, skills, and accomplishments

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Regulatory Affairs, or another relevant field.
• Minimum 3–5 years of experience in CMC regulatory affairs, regulatory intelligence, pharmaceutical development, quality/manufacturing compliance, or related life sciences roles.
• Strong understanding of CMC requirements, CTD structure (Module 3), and global regulatory frameworks (FDA, EMA, ICH, LATAM, APAC).
• Strong ability to independently interpret, synthesize, and contextualize CMC regulatory requirements.
• Demonstrated ability to apply judgment in ambiguous or evolving regulatory scenarios.
• Experience contributing to content strategy, standardization, or data model improvements.
• Experience evaluating regulatory guidelines, quality standards (e.g., ICH Q-series), and CMC-related regulatory updates.
• Familiarity with structured data environments, content management systems, or regulatory databases.
• Experience working with AI-assisted editorial workflows or validating AI-generated outputs.
• Excellent written communication skills, with strong attention to detail and editorial precision.
• Ability to analyze complex CMC regulatory information and translate it into clear, structured, and standardized content.
• Ability to work effectively with global, cross-functional, and remote teams.
• Fluency in English; additional languages are an asset.

It would be great if you also had…

• Prior experience developing CMC regulatory intelligence or structured regulatory content.
• Knowledge of regulatory lifecycle management, including submissions, approvals, and post-approval changes (variations, supplements).
• Experience engaging with external consultants or local regulatory experts to validate country-specific requirements.
• Understanding of regulatory intelligence methodologies, including requirement comparison, trend tracking, and local practices.
• Familiarity with quality management systems, data governance, and content standardization frameworks.
• Exposure to AI/ML-enabled content production, automation, or digital transformation initiatives in regulatory affairs.

What will you be doing in this role?

• Monitor global and regional CMC regulatory developments, including guidelines, quality standards, and country-specific requirements from health authorities.
• Independently interpret and contextualize complex CMC regulatory updates, assessing their impact on the database content.
• Transform regulatory changes into structured, high-quality intelligence for CMCi databases and country modules.
• Analyze CMC requirements within the CTD framework and identify deviations and country-specific nuances.
• Conduct in-depth assessment of regulatory guidance and updates, identifying impacts on manufacturing, control strategy, submissions, and lifecycle management.
• Collaborate with AI-enabled content production workflows to enrich data, improve efficiency, and apply expert oversight for quality assurance.
• Ensure accuracy, consistency, and traceability of structured regulatory data within the CMC database.
• Coordinate with external consultants and local experts to validate complex or ambiguous country-level CMC regulatory practices.
• Perform quality control (QC) and validation activities to ensure alignment with editorial standards and data governance requirements.
• Proactively communicate key CMC regulatory insights to internal teams, editorial stakeholders, and customer-facing functions.
• Actively contribute to cross-functional initiatives, influencing AI-assisted workflow optimization, product enhancements, data quality frameworks, and global harmonization strategies.
• Identify gaps, inconsistencies, or risks in content and drive corrective or preventive actions.

About the Team

As part of the Regulatory Market Access team, CMC is a group of subject matter experts and is mainly responsible to curate content through monitoring and editing official worldwide guidelines and legislation related to the CMC area, for both pre- and post-approval content.It works closely with cross-functional teams including Product, Tech, Customer Care, supports internal and external stakeholders and contributes to Clarivate’s mission to improve innovation through curated content and technology.

The team is spread across different locations: France, Malaysia, India, Serbia, Spain, US.

Hours of Work  

Hybrid work mode. The work timing is 8-9AM / 5-6PM IST.

At Clarivate, we are committed to providing equal employment opportunities for all qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.