About You – experience, education, skills, and accomplishments
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Regulatory Affairs, or another relevant field.
- 1–2 years of experience in the pharmaceutical industry, preferably in CMC manufacturing or CMC regulatory affairs.
- Basic understanding of CMC requirements and global regulatory frameworks (FDA, EMA, ICH).
- Familiarity with structured data environments, content management systems.
- Exposure to AI‑assisted workflows, data validation, or review of AI-generated content.
- Excellent written communication skills, attention to detail, and editorial precision.
- Ability to analyze regulatory information and translate it into clear, structured, and standardized content under guidance.
- Ability to follow defined methodologies, templates, and editorial standards to ensure consistency of structured content.
- Ability to collaborate effectively and resolve challenges in a matrix organization.
- Capability to work remotely with peers in an international environment.
- Strong problem-solving skills and sound judgment in prioritization and decision-making.
- Team spirit, good communication skills and pro-activity.
- Fluent in English.
It would be great if you also had . . .
- Knowledge of ICH quality guidelines for small molecules and/or biologics.
- Exposure to regulatory submissions (e.g., MAA, BLA, ANDA), responses to deficiency letters, and interactions with health authorities.
- Understanding of regulatory intelligence concepts (requirement comparison, local practices…).
- Knowledge of another European language.
What will you be doing in this role?
- Maintain, curate, and continuously update the global CMC regulatory database to ensure accuracy, consistency, and traceability of content.
- Monitor and track regulatory CMC updates, identifying new guidelines, regulatory trends, and country-specific requirements, and escalate relevant changes.
- Support the analysis of regulatory changes and translate into structured, standardized content following defined methodologies.
- Capture and document differences between local regulatory requirements and the standard CTD framework.
- Collaborate with a network of external consultants and subject matter experts to validate local practices and ensure content reliability.
- Contribute to content preparation supporting product updates and enhancements.
- Support internal stakeholders (Product, Tech, Customer Care) by providing regulatory expertise and clarifications when needed.
- Support responses to customer queries under supervision, ensuring accuracy and alignment with existing content
- Work within defined workflows, applying editorial rules, taxonomies, and data structures consistently
- Perform quality checks (QC) and validation activities to ensure alignment with internal quality standards, editorial guidelines, and content governance processes.
- Participate in continuous improvement initiatives aimed at increasing efficiency, automation, and data quality within content operations.
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.
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, Regulatory Affairs, or another relevant field.
- 1-2 years of experience in the pharmaceutical industry, preferably in CMC manufacturing or CMC regulatory affairs.
- Basic understanding of CMC requirements and global regulatory frameworks (FDA, EMA, ICH).
- Familiarity with structured data environments and content management systems.
- Exposure to AI-assisted workflows, data validation, or review of AI-generated content.
- Excellent written communication skills, attention to detail, and editorial precision.
- Ability to analyze regulatory information and translate it into clear, structured, and standardized content under guidance.
- Ability to follow defined methodologies, templates, and editorial standards to ensure consistency of structured content.
- Ability to collaborate effectively and resolve challenges in a matrix organization.
- Capability to work remotely with peers in an international environment.
- Strong problem-solving skills and sound judgment in prioritization and decision-making.
- Team spirit, good communication skills and pro-activity.
- Fluent in English.
- Knowledge of ICH quality guidelines for small molecules and/or biologics.
- Exposure to regulatory submissions (e.g., MAA, BLA, ANDA), responses to deficiency letters, and interactions with health authorities.
- Understanding of regulatory intelligence concepts (requirement comparison, local practices…).
- Knowledge of another European language.
Clarivate Analytics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Clarivate Analytics and has not been reviewed or approved by Clarivate Analytics.
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Strong & Reliable Incentives — Incentives in sales and select product/tech roles provide meaningful upside for high performers, with commission structures boosting total compensation when targets are exceeded. Role-linked variable pay is a clear strength in revenue-driving positions.
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Leave & Time Off Breadth — PTO is ample in the U.S., with paid parental leave available, making time-off policies a notable part of the package. Generous vacation and holiday allowances stand out as positives.
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Wellbeing & Lifestyle Benefits — Hybrid and remote options are common and paired with a formal wellbeing framework and EAP, supporting work–life balance. Core medical, dental, and vision coverage is broadly available in the U.S., reinforcing everyday wellbeing support.
Clarivate Analytics Insights
What We Do
Clarivate™ is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world’s most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise. For more information, please visit clarivate.com.
