Senior STEM Content Analyst

5 - 9 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Senior STEM Content Analyst with expertise in CMC Biologics, you will be a valuable addition to the Life Sciences team in India. Your primary responsibility will be to monitor regulatory changes, author detailed CMC reports, and provide support to internal teams and external customers. Collaboration with global teams, meticulous management of complex regulatory data, and contribution to product innovation will be essential for your success in this role. **Qualifications Required:** - Minimum BS degree in Life Sciences - 5+ years of experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs for Biologics/Biopharmaceuticals - Experience managing BLA/MAA content and format - Strong knowledge of ICH requirements for quality aspects for Biologics and/or Biopharmaceutical products - Understanding of scientific principles relevant to vaccine and biologics development - Excellent communication, problem-solving, and decision-making skills **Responsibilities:** - Author high-quality CMC reports for biologics to support regulatory submissions - Monitor and analyze global CMC regulatory changes - Act as internal CMC regulatory expert for assigned countries - Collaborate with cross-functional teams including Product, Tech, Customer Care - Participate in special projects and editorial/content operations In addition to the job specifics, the Regulatory Market Access team at Clarivate plays a crucial role in curating content related to the CMC area by monitoring and editing official worldwide guidelines and legislation. The team operates globally and collaborates closely with cross-functional teams, supporting internal and external stakeholders while contributing to Clarivate's mission to enhance innovation through curated content and technology. In terms of work hours, you can expect a hybrid work mode (Monday - Friday) from 10 AM to 6 PM IST. At Clarivate, equal employment opportunities are provided, and the company complies with laws and regulations governing non-discrimination in all locations.,

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Clarivate

Information Services

London Penang

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