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.
About You Experience, Education, Skills, And Accomplishments??
- BS degree in Life Sciences.
- Minimum of 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
It would be great if you also had . . .?
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- 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
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- 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.
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.
Hours of Work?
?This is a full-time permanent position, with flexible 8 working hours/day in core time of 9:00am-6:00pm (IST). Workdays - Monday to Friday.
Work Mode
: HybridAt 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.
