Clarivate, a global leader in providing trusted insights and analytics, is hiring an Associate STEM Content Analyst specializing in CMC Regulatory Market Access. This is a fantastic opportunity for professionals with expertise in pharmaceutical development, regulatory affairs, and compliance.
Job Description
Key Responsibilities:
✅ Database Maintenance: Manage and update the CMC regulatory database, ensuring compliance with global regulatory changes.
✅ Regulatory Monitoring: Track evolving CMC regulatory requirements worldwide and implement updates in the database.
✅ Expert Collaboration: Work with external consultants to maintain accurate regulatory intelligence.
✅ Customer Support: Act as a team representative for customer queries and internal stakeholders.
✅ Administrative Tasks: Identify local CMC experts, negotiate contracts, and manage copyright agreements.
Required Qualifications:
✔ Education: Graduate or Postgraduate in Life Sciences (Pharmacy, Biotechnology, etc.).
✔ Experience: Minimum 1+ years in pharmaceutical development, CMC manufacturing, or CMC regulatory affairs.
✔ Regulatory Knowledge: Strong understanding of ICH guidelines, drug development quality standards, and post-approval changes.
✔ Submission Expertise: Experience in regulatory submissions, deficiency responses, and health authority communications.
Preferred Skills:
🔹 Knowledge of Biological entities (Biologics/Biosimilars).
🔹 Proficiency in a European language (German, French, Spanish, etc.).
About Clarivate
Clarivate is a global leader in analytics and regulatory intelligence, helping pharmaceutical and life sciences organizations navigate complex compliance landscapes. Our Regulatory Intelligence teams synthesize critical data to support drug development and market access.
Work Details
📅 Job Type: Full-time, Permanent
⏰ Working Hours: 9 AM – 6 PM IST
🏢 Work Mode: Hybrid (Office + Remote)
