Global Regulatory Affairs / Labelling

Sanofi is hiring GRA Labelling Specialist for its Global Regulatory Affairs (GRA) function in Hyderabad.

Sanofi is a global pharmaceutical and healthcare company involved in the research, development, manufacturing and commercialization of medicines and vaccines.

💼 Position Details

• Company: Sanofi

• Position: GRA Labelling Specialist

• Department/Function: Global Regulatory Affairs – Labelling

• Job Requisition ID: R2869261

• Location: Hyderabad, India

• Work Model: Hybrid

• Employment Type: Full-time

• Application Deadline: September 30, 2026

🎓 Educational Qualification

• Bachelor’s degree in Life Sciences or equivalent

• Relevant experience in Regulatory Affairs, Labelling, or a highly regulated pharmaceutical environment

👨‍💼 Experience Required

• 3–5 years of relevant industry or functional experience

• Experience in Regulatory Affairs / Drug Labelling is preferred.

• Knowledge of pharmaceutical labelling principles and requirements.

📋 Key Responsibilities

Drug Labelling

• Prepare and update corporate labelling documents for marketed and lifecycle products.

• Work on CCDS, USPI and EU SmPC and corresponding patient text.

• Ensure labelling documents comply with applicable regulatory requirements.

Regulatory Submissions

• Coordinate the end-to-end labelling review and approval process.

• Prepare labelling components for regulatory submissions.

• Support Health Authority negotiations and regulatory discussions.

• Coordinate release of approved labelling for company use.

Cross-Functional Collaboration
Work closely with:

• Global Regulatory Affairs

• Global Pharmacovigilance

• Global Medical Affairs

• Legal

• Preclinical

• CMC teams

Health Authority Support

• Prepare company/MAH responses to Health Authority questions related to labelling.

• Support local countries during labelling negotiations and Health Authority discussions.

• Participate in response teams for European arbitration/referrals, work-sharing procedures and PRAC-related activities.

Labelling Strategy

• Connect regulatory strategy with labelling strategy.

• Identify potential challenges and escalate them appropriately.

• Present labelling proposals to senior management and the Labeling Governance Committee.

• Perform competitive/comparator labelling analysis.

🧪 Technical Skills

Candidates should have knowledge of:

• Pharmaceutical drug labelling principles

• CCDS, USPI and EU SmPC

• EU and US labelling requirements

• Health Authority regulations and guidelines

• Regulatory Affairs processes

• Company SOPs

• Labelling strategy

• Health Authority responses

• Competitive labelling analysis

⭐ Key Soft Skills

• Excellent written and verbal communication

• Strong analytical and critical-thinking skills

• Project management and organizational skills

• Problem-solving abilities

• Stakeholder management

• Ability to lead multidisciplinary teams

• Negotiation and consensus-building skills

• Strong attention to detail

• Ability to manage multiple projects

• Self-starter and ability to work independently

• Fluent business English

👤 Suitable Candidates

This position is particularly suitable for professionals with experience in:

• Regulatory Affairs

• Regulatory Labelling

• Global Regulatory Affairs

• Pharmaceutical labelling

• Health Authority interactions

• Highly regulated pharmaceutical environments