We are looking for a Senior STEM Content Analyst with strong expertise in CMC Biologics to join our Life Sciences team in India The ideal candidate will have a solid background in pharmaceutical development or regulatory affairs particularly in biologics and biopharmaceuticals and will be passionate about delivering high-quality 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 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 Minimum BS degree in Life Sciences 5 years in pharmaceutical development CMC manufacturing or CMC regulatory affairs for Biologics Biopharmaceuticals Experience managing BLA MAA content and format Experience with FDA and EMA submissions including responses to deficiency letters and communications with health authorities on quality aspects of the product Working knowledge experience in regulatory submission and approval processes for current Biologics or biopharmaceutical products and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements Strong knowledge of ICH requirements for quality aspects for Biologics and or Biopharmaceutical products Understanding of scientific principles relevant to vaccine and biologics development Ability to work in global teams and remote environments with extended multinational project teams on multiple tasks under pressure of time and workload Demonstrated ability to work collaboratively and resolve conflict across different functional areas in a highly matrixed organization Excellent communication problem-solving and decision-making skills Fluent in English additional languages appreciated It would be great if yo

📌 Senior Stem Content Analyst (Chennai)
🏢 Clarivate
📍 Chennai