Senior STEM Content Analyst

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   

• BS degree in Life Sciences.  

• Atleast 5 years of experience 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 new 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. 

• It would be great if you also had . . .   

• Knowledge of biological entities. 

• Experience negotiating contracts and managing budgets/invoices. 

• Familiarity with copyright terms and local expert networks. 

What will you be doing in this role?  

• Author high-quality CMC reports for biologics to support regulatory submissions, facilitate the application of CMC global regulatory strategies, helping to assure technical congruency and regulatory compliance with customers. 

• Monitor and analyze global CMC regulatory changes. 

• Analyze changes in the CMC requirements and implement changes in the database capitalizing on internal expertise and the external network of consultants for local expertise and practice. 

• Act as internal CMC regulatory expert for assigned countries. 

• Support CMC Product Manager and provide customer expertise, acting as team representative for customers when required. 

• Collaborate with Product, Tech, Customer Care, and other stakeholders. 

• 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   10:00 AM to 6:00 PM

Work Mode: Hybrid (Monday to Friday) Location: Chennai