Sanofi is hiring a GRA Labelling Specialist in Hyderabad. Candidates with a bachelor’s degree in Life Sciences and at least three years of experience in Regulatory Affairs, pharmaceutical labeling, or another highly regulated environment can apply.

The position follows a hybrid working model and focuses on preparing and maintaining global pharmaceutical labeling documents, including CCDS, USPI, EU SmPC, and patient information texts.

Sanofi GRA Labelling Specialist Recruitment 2026

Sanofi has announced an experienced-level Regulatory Affairs opportunity for its Hyderabad location. The selected candidate will coordinate end-to-end labeling activities for marketed and lifecycle pharmaceutical products.

This role is particularly suitable for regulatory professionals who understand global drug-labeling requirements and can work with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, CMC, and preclinical teams.

Job Overview

What Does a GRA Labelling Specialist Do?

A GRA Labelling Specialist develops, reviews, coordinates, and maintains regulated product-labeling documents. The specialist ensures that prescribing information, patient text, and other labeling materials comply with company procedures and health-authority requirements.

The Sanofi GRA Labelling Specialist will also lead labeling discussions and help multidisciplinary teams reach agreement on safety, medical, regulatory, and product information.

Key Responsibilities

The selected candidate will be responsible for:

• Preparing and updating corporate labeling documents such as CCDS, USPI and EU SmPC.
• Developing corresponding patient information and patient-labeling text.
• Coordinating labeling review and approval across the end-to-end labeling process.
• Preparing labeling components for submission to regulatory agencies.
• Supporting negotiations with health authorities for product approvals and labeling updates.
• Releasing approved labeling for use across the company.
• Acting as a labeling expert within cross-functional Labeling Working Groups.
• Contributing to global regulatory and product-labeling strategies.
• Supporting preparation of labeling components for regulatory submission dossiers.
• Preparing responses to questions received from health authorities.
• Supporting maintenance and compliance of existing Marketing Authorizations.
• Participating in European referrals, arbitration procedures and work-sharing activities.
• Supporting responses to PRAC questions associated with safety-signal evaluation.
• Creating labeling proposals for presentation to senior management and governance committees.
• Performing competitive and comparator labeling analyses.
• Meeting established regulatory submission timelines and quality standards.
• Chairing multidisciplinary labeling working-group meetings.
• Resolving labeling disagreements and building consensus among stakeholders.
• Supporting local country teams during health-authority discussions and labeling negotiations.

Who Can Apply?

Candidates should meet the following eligibility requirements:

• Bachelor’s degree in Life Sciences or an equivalent discipline.
• At least three years of relevant professional experience.
• Overall relevant experience of approximately 3–5 years.
• Experience in Regulatory Affairs, pharmaceutical labeling, or an equivalent highly regulated environment.
• Knowledge of global drug-labeling principles and processes.
• Understanding of labeling requirements in the United States and European Union.
• Fluency in business English.

Relevant educational backgrounds may include degrees in pharmacy, pharmaceutical sciences, life sciences, biotechnology, biochemistry, microbiology, or related disciplines. However, Sanofi officially states “Bachelor’s degree in Life Sciences or equivalent,” so final eligibility will be determined by its recruitment team.

This vacancy is not intended for freshers, because relevant Regulatory Affairs or labeling experience is mandatory.

Technical and Domain Skills

Candidates should have knowledge or experience in:

• Global pharmaceutical labeling
• Core Company Data Sheets (CCDS)
• United States Prescribing Information (USPI)
• European Summary of Product Characteristics (EU SmPC)
• Patient information and patient labeling
• Regulatory submissions
• Health-authority regulations and guidance
• Marketing Authorization maintenance
• Labeling strategy development
• Pharmacovigilance and safety-signal implications
• PRAC questions and European referral procedures
• Regulatory intelligence
• Labeling competitor and comparator analysis
• Company SOP interpretation
• Scientific and public-data research
• Regulatory project management

Soft Skills Required

Sanofi is looking for candidates with:

• Excellent written and verbal communication
• Strong attention to detail
• Analytical and critical-thinking ability
• Problem-solving skills
• Stakeholder-management capability
• Conflict-resolution and negotiation skills
• Organizational and networking skills
• Ability to manage several projects simultaneously
• Ability to lead multidisciplinary working groups
• Confidence working with domestic and international stakeholders
• Ability to work independently on routine assignments

Is This a Regulatory Affairs Job?

Yes. The GRA Labelling Specialist position is a Global Regulatory Affairs job focused specifically on pharmaceutical product labeling.

Although the specialist collaborates with Pharmacovigilance, Medical Affairs, Legal and CMC teams, the core function is regulatory labeling strategy, document preparation, health-authority compliance, and Marketing Authorization maintenance.

Benefits and Work Environment

The job description confirms:

• Full-time employment
• Hybrid working model in Hyderabad
• Opportunity to work with global and multidisciplinary teams
• Exposure to global regulatory labeling activities
• Equal employment opportunities
• A professional environment focused on pharmaceutical research and patient outcomes

Other benefits, bonuses, insurance coverage, leave policies, and allowances were not clearly specified in the official job description.

How to Apply

Application Link