GRA Labelling Specialist

Overview

GRA Labelling Specialist to prepare, coordinate, and release corporate drug labeling documents and support regulatory labeling strategy across global lifecycle and marketed products.

What you'll do

• Prepare or update corporate labeling documents for assigned products (CCDS, USPI, EU SmPC) and corresponding patient text.
• Coordinate labeling review and approval across an end-to-end labeling process, including submission component prep.
• Participate in labeling negotiations with agencies and support product approvals or labeling updates.
• Support cross-functional teams as a labeling expert and contribute to global regulatory strategy inputs.
• Maintain compliance for existing Marketing Authorizations, including participation in response/referral procedures and PRAC questions.
• Create and present labeling proposals to Senior Executive Management through the Labeling Review Committee.

What you'll need

• 3–5 years of relevant industry or functional experience.
• Knowledge of labeling principles (including generics) and drug labeling requirements (CCDS EU, US).
• Ability to read and interpret Health Authority regulations, guidances, and relevant company SOPs.
• Experience leading multidisciplinary labeling working groups and building consensus.
• Ability to construct company responses (MAH response) to EU/US health authority labeling questions.
• Fluent business English for written and verbal communication.

Details

• Location: Hyderabad, India.
• Work mode: Hybrid model.