Associate STEM Content Analyst at Clarivate, BSc/MSc Lifescience candidates can apply!
Clarivate is seeking a detail-oriented Associate STEM Analyst to join our CMC Regulatory Market Access team. Located in Tamil Nadu, India, this hybrid role offers an exciting opportunity to contribute to product development by maintaining and enhancing our CMC regulatory database. You will be part of a collaborative team of 43 colleagues, reporting to the Content Manager. If you have a background in Life Sciences and experience in pharmaceutical development, CMC manufacturing, or regulatory affairs, with a strong understanding of quality aspects and ICH requirements, we encourage you to apply.
Location: Tamil Nadu, India
Remote: Hybrid
Job ID: JREQ132296
Posted Date: May 13th 2025
About You – experience, education, skills, and accomplishments
- Graduate or Postgraduate in Life Sciences.
- At least 1 year of experience in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs.
- Strong knowledge of quality aspects of drug development and ICH requirements.
- Experience with submissions, post-approval changes, responses to deficiency letters, and communications with health authorities on quality aspects of the product is required.
It would be great if you also had . . .
- Knowledge of Biological entities would be appreciated.
- Knowledge of another European language.
What will you be doing in this role?
- Maintenance of the CMC regulatory database.
- Monitor the evolution of the CMC regulatory landscape worldwide.
- Analyze the changes in the CMC requirements and implement them in the database. The content editor must act as an internal expert for a set of countries.
- Work in collaboration with a pool of external consultants.
- Administrative tasks.
- Undertake the research and identification of local CMC experts, negotiation of contract terms, and copyrights when needed.
- Provide support and act as a team representative for customers when required.
- Communicate relevant information to concerned stakeholders.
About the Team
Regulatory Intelligence information is part of the Life Science and comprises several teams responsible for the daily collection, synthesis, and maintenance of data relating to regulatory information. These records form a core element of Product.
Hours of Work
- Full-time.
- Permanent role.
- Team working hours – 9 am to 6 pm IST and Hybrid work mode.
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.
Keywords- Associate STEM Content Analyst, Clarivate, CMC Regulatory Affairs, Pharmaceutical Development, Life Sciences, Regulatory Intelligence, ICH Guidelines, Drug Quality, CMC Manufacturing.
