GRA Labeling Specialist

About the role

The GRA Labeling Specialist at Sanofi India Limited’s Regulatory Affairs team drives labeling value to maximize Sanofi’s competitive advantage. Day-to-day, the role prepares and updates corporate labeling documents (CCDS, USPI, EU SmPC) and patient text for marketed and lifecycle products, coordinates end-to-end labeling review and approval, supports cross-functional labeling working groups, and presents labeling proposals to senior management. Based in Hyderabad, India, this is a hybrid role.

What you’ll do

• Prepare and/or update corporate labeling documents (CCDS, USPI, EU SmPC) and corresponding patient text for assigned marketed and lifecycle products for company and/or agency approval
• Coordinate labeling review and approval throughout the E2E labeling process, including preparation of labeling components for submission to regulatory agencies and participation in labeling negotiatio
• Support cross-functional teams (LWG) as a labeling expert and contribute to global regulatory strategy and preparation of labeling components of submission dossiers or responses to Health Authorities
• Support maintenance and compliance of existing Marketing Authorizations, including membership in Response Teams for procedures such as European Arbitration/referrals, work sharing, and PRAC questions
• Coordinate and create the presentation of labeling proposals to Senior Executive Management via the Labeling Review Committee
• Perform labeling competitive/comparator analysis
• Chair multi-disciplinary labeling working groups, present labeling proposals, and develop/reach consensus for presentation to the Labeling Governance Committee for internal approval
• Support local countries as a global labeling SME during labeling negotiation and HA discussion

What you’ll bring

• Bachelor’s degree in Lifesciences or equivalent
• 3–5 years of relevant industry or functional experience
• 3+ years of related work experience in Regulatory Affairs/Labeling or equivalent in a highly regulatory environment
• Knowledge of the principles and concepts of Labeling (including generics)
• Knowledge of labeling requirements for drugs (CCDS EU, US)
• Ability to read and interpret HA regulations and guidances and relevant company SOPs
• Fluent business English
• Ability to work autonomously for routine tasks with oversight on more complex topics as needed

Skills

Education

Bachelor’s degree in Lifesciences or equivalent, with 3 plus years of related work experience in Regulatory Affairs/Labeling or equivalent in highly regulatory environment