Senior GRA Labeling Specialist

About the role

The Senior GRA Labeling Specialist at Sanofi India Limited (Hyderabad, India) drives labeling value to maximize Sanofi's competitive advantage within the Regulatory Affairs department. Day-to-day, the role leads labeling strategy, 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, and participates in labeling negotiations with health authorities. The specialist chairs multi-disciplinary labeling working groups, supports cross-functional teams as a labeling expert, and contributes to global regulatory strategy and submission dossiers. This is a hybrid position based in Hyderabad.

What you’ll do

• Lead Labeling Strategy, prepare and/or update corporate labeling documents (CCDS, USPI and EU SmPC) and corresponding patient text for assigned marketed and life cycle products (including line extensi
• Coordinate labeling review and approval throughout the E2E labeling process, including preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations
• Support cross-functional teams as an experienced labeling expert (LWG and GRT) and contribute to the global regulatory strategy and to the preparation of labeling components of submission dossiers or
• Chair multi-disciplinary labeling working groups, presenting labeling proposals and developing/reaching consensus on proposals resulting in presentation of labeling proposals to the Labeling Governanc
• For the maintenance and compliance of existing Marketing Authorizations (be a member of Response Teams within procedures such as European Arbitration/referrals, or work sharing, PRAC questions (signal
• Anticipates any hurdles in implementation, informs manager and acts to minimize them.
• Coordinate, create and be proficient in presenting labeling proposals to Senior Executive Management via Labeling Review Committee.
• Assess relevant study reports, pharmacovigilance data (post-marketing) and any other scientific reports required for support labeling proposals.

What you’ll bring

• Bachelor's degree in a scientific discipline, or relevant/equivalent with 5 years of experience in Regulatory Affairs (including 2 years direct Labeling experience) or equivalent in a highly regulated
• 6–8 years of relevant experience demonstrating advanced capability.
• Knowledge of the principles and concepts of Labeling (including generics, authorized generics, private labels, device/combination products) and the dynamics of Labeling Team purpose and objectives.
• Demonstrated knowledge of labeling requirements for drugs (CCDS EU, US).
• Ability to read and interpret HA regulations and guidance, and relevant company SOPs.
• Fluent business English.
• Strong ability to lead a multidisciplinary labeling working group and provide labeling strategy proposal, negotiate, resolve conflict and build consensus.
• Ability to construct a Company Response (MAH response) for health authority (EU/US) questions related to labeling.

Skills