Generic Medicine Specialist

7 days ago


Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 1,84,32,000 - ₹ 2,19,08,000
Regulatory Affairs Position Overview

We seek a highly skilled professional to join our team and contribute to the development of generic medicines.

This role involves collaborating with the world's leading manufacturer of generic medicines, working on products featured on the World Health Organization's Essential Medicines List.

The ideal candidate will ensure the accuracy of product information for European procedures, including innovative, biosimilar, and generic products.

  • Provide internal pharmaceutical and medical expertise to address inquiries and resolve labeling issues.
  • Maintain regulatory compliance for all maintained EU procedures regarding labeling.
Key ResponsibilitiesProduct Information Management
  • Create and update compliant English product information for EU procedures.
  • Offer guidance on local RA operations, such as calculations for new excipients warnings.
  • Participate in project teams to discuss product information content for innovative products (pre- and post-approval).
Monitoring and Safety Updates
  • Communicate monthly safety updates from EU authority websites.
  • Track reference product updates and legal/guidance changes affecting product information.
Pharmacovigilance
  • Assess the need for updates based on Company Core Safety Information (CCSI).
  • Implement PV-triggered and non-PV-triggered safety updates in line with SOPs, collaborating with Pharmacovigilance and QA.
Scientific Work & Authority Communication
  • Respond to authority deficiency letters in collaboration with other departments.

5-6 years of experience in relevant fields, preferably in Regulatory Affairs.

A degree in natural sciences, such as Pharmacy (preferred), Biology, Human Biology, Medicine, or Food Chemistry, is required.



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