Senior Content Analyst - Pharmaceutical CMC (Small Molecules & Biologics)

Senior STEM Content Analyst- CMC and Regulatory Professional (Small Molecules/Biologics)

We are looking for a Senior STEM Content Analyst with strong expertise in CMC Small Molecules and/or Biologics to join our Life Sciences team in India. The ideal candidate will have a solid background in pharmaceutical development and/or regulatory affairs across CTD/eCTD submissions and product lifecycle management, particularly in small molecules/biologics and biopharmaceuticals—and combines this expertise with the ability to leverage AI‑driven tools and techniques to enhance the accuracy, efficiency, and scalability of regulatory content development. They will be passionate about delivering high-quality, data-driven content that supports global health authority submissions.

You will be responsible for monitoring regulatory changes, authoring detailed CMC reports, and supporting both internal teams and external customers. Your ability to work collaboratively across global teams, within AI enhanced editorial workflows, manage complex regulatory data, and contribute to product innovation will be key to your success in this role.  

About You – experience, education, skills, and accomplishments  

• BS degree in Life Sciences (Pharmacy, Chemistry, Biochemistry, Biotechnology).
• Minimum of 5+ years in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Small Molecules and/or Biologics.
• Proven authorship/review of CTD/eCTD Module 3 (3.2.S / 3.2.P) and Module 2.3/QOS; familiarity with NDA/ANDA/BLA/MAA and post‑approval changes.
• Experience managing BLA/MAA content and FDA/EMA submissions, including deficiency responses and quality‑related communications, with strong understanding of regulatory processes for Small Molecules, Biologics, and product lifecycle management.
• Solid knowledge of complex CMC regulatory requirements and ICH quality guidelines for Small Molecules and Biologics.
• Proven ability to work effectively in global, multicultural, and remote teams—managing multiple tasks under pressure, collaborating across functions, resolving conflicts, and operating within highly matrixed environment.
• Strong communication, problem‑solving, and decision‑making skills, with experience reviewing AI‑assisted content tools; fluent in English with additional languages as an advantage.

It would be great if you also had . . .  

• Understanding of scientific principles relevant to vaccine and biologics development.
• Knowledge of biological entities.
• Experience negotiating contracts and managing budgets/invoices.
• Familiarity with copyright terms and local expert networks.
• Practical experience using NLP/LLMs to analyze, summarize, and structure regulatory/CMC texts.
• Ability to design prompting strategies, build taxonomies/ontologies for CMC concepts, and perform semantic search.

What will you be doing in this role? 

• Author high‑quality CMC reports for Small Molecules and Biologics to support regulatory submissions and ensure alignment with global CMC strategies.
• Monitor and analyze global CMC regulatory changes and update internal databases using both internal and external expertise.
• Serve as the internal CMC regulatory expert for assigned countries and support the CMC Product Manager as needed.
• Provide subject‑matter expertise to guide and validate AI‑assisted content generation and collaborate with AI‑enabled workflows to improve efficiency.
• Work with Product, Tech, Customer Care, and other stakeholders, and participate in special projects and editorial/content operations.

About the Team   

As part of the Regulatory Market Access team, CMC is 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 between 8:00 AM- 6:00 PM,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.

Experience Level

Senior Level