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Sanofi GRA Labelling Specialist Job in Hyderabad
Published on: October 8, 2026
Sanofi is hiring for a GRA Labelling Specialist in Hyderabad, India. The role focuses on pharmaceutical labelling within Global Regulatory Affairs and involves coordinating with Regulatory Affairs, Medical Affairs, Pharmacovigilance, and other cross-functional teams.
1. Sanofi GRA Labelling Specialist – Job Details
| Particular | Details |
|---|---|
| Company | Sanofi |
| Job Title | GRA Labelling Specialist |
| Location | Hyderabad, India |
| Work Model | Hybrid |
| Function | Global Regulatory Affairs / Labelling |
| Job Type | Full-time |
| Official Job Posting | Sanofi GRA Labelling Specialist – Hyderabad |
2. Eligibility
| Requirement | Details |
|---|---|
| Education | Bachelor’s degree in Lifesciences or equivalent |
| Experience | 6–9 years of relevant industry or functional experience |
| Relevant Experience | Regulatory Affairs / Labelling or equivalent |
| Industry | Highly regulated environment |
| Language | Fluent business English |
The job description also mentions 3+ years of related work experience in Regulatory Affairs/Labeling or equivalent in its education section. However, the vacancy separately lists 6–9 years of relevant industry or functional experience. Candidates should review the official posting carefully when assessing their eligibility.
3. About the Role
The GRA Labelling Specialist will work on preparing, reviewing and maintaining product labelling for marketed and lifecycle products.
The role covers the labelling process from internal review and regulatory submissions to health authority interactions and implementation of approved labelling updates.
The vacancy specifically mentions the following labelling documents and activities:
| Area | Details |
|---|---|
| Global Core Labelling | CCDS |
| US Labelling | USPI |
| European Labelling | EU SmPC |
| Patient Information | Corresponding patient text |
| Regulatory Activities | Health authority questions and negotiations |
| Lifecycle Activities | Labelling updates and Marketing Authorization maintenance |
If you are exploring a career in Regulatory Affairs, you can also read our guide on Career in Regulatory Affairs After B.Pharm for an overview of the field and possible career paths.
4. Key Responsibilities
The Sanofi job description includes responsibilities such as:
- Prepare and update corporate labelling documents such as CCDS, USPI and EU SmPC.
- Prepare the corresponding patient information.
- Coordinate end-to-end labelling reviews and approvals.
- Prepare labelling components for regulatory submissions.
- Support discussions and negotiations with health authorities on labelling matters.
- Support Marketing Authorization maintenance and required labelling updates.
- Prepare responses to health authority questions related to labelling.
- Support European arbitration and referral procedures, work-sharing activities and PRAC-related questions.
- Review competitive and comparator labelling.
- Support Labelling Working Groups (LWG) as a subject-matter expert.
- Work closely with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, preclinical and CMC teams.
- Lead multidisciplinary discussions, help resolve issues and work towards agreement on labelling proposals.
The position also involves delivering work within established timelines and quality standards.
5. Skills Required
The role requires a combination of labelling knowledge, regulatory understanding and strong coordination skills.
| Skill Area | What Sanofi Looks For |
|---|---|
| Labelling | Knowledge of pharmaceutical labelling principles and concepts |
| Regulatory Knowledge | Understanding of EU and US labelling requirements |
| Regulations | Ability to work with health authority regulations, guidance and SOPs |
| Regulatory Strategy | Understanding of how regulatory strategy connects with labelling strategy |
| Communication | Strong written and verbal communication |
| Coordination | Experience working with multidisciplinary teams |
| Leadership | Experience leading labelling working groups |
| Problem Solving | Critical thinking, conflict resolution and sound judgement |
| Project Management | Managing multiple projects and timelines |
| Analysis | Strong analytical and detail-oriented approach |
| Negotiation | Handling discussions, resolving issues and building consensus |
| Scientific Knowledge | Knowledge of statistics and relevant disease areas |
| Data Research | Ability to research publicly available information related to labelling |
6. Cross-Functional Collaboration
The position requires regular interaction with several functions:
| Team / Function | Area of Interaction |
|---|---|
| Global Regulatory Affairs | Regulatory strategy and submissions |
| Pharmacovigilance | Safety information and labelling |
| Medical Affairs | Medical and scientific content |
| Legal | Labelling-related review |
| CMC | Chemistry, manufacturing and controls information |
| Preclinical | Non-clinical information |
| Senior Management | Labelling proposals and governance |
| Health Authorities | Questions, negotiations and approvals |
You can also find related opportunities on our Regulatory Affairs Jobs page.
7. How to Apply
Eligible candidates can apply through the official Sanofi Careers website.
- Review the complete job description and eligibility requirements.
- Make sure your qualifications and experience match the vacancy.
- Open the job posting and click Apply Now to submit your application.
Sanofi Careers – Job Search: Search Sanofi Jobs
GRA Labelling Specialist – Apply Now: Apply for GRA Labelling Specialist
Please review the official job description carefully before applying.
8. Frequently Asked Questions
| Question | Answer |
|---|---|
| What does a GRA Labelling Specialist do? | The role focuses on pharmaceutical labelling, regulatory submissions, health authority interactions and lifecycle labelling activities. |
| Which labelling documents are involved? | The vacancy mentions CCDS, USPI and EU SmPC, along with corresponding patient text. |
| Is Regulatory Affairs experience relevant? | Yes. The position requires experience in Regulatory Affairs, Labelling or an equivalent function. |
| Does the role involve cross-functional work? | Yes. The position involves collaboration with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Legal, CMC, preclinical and other teams. |
| Can freshers apply? | The stated 6–9 years of relevant experience requirement means this vacancy is intended for experienced professionals. |
| Where can I apply? | Applications can be submitted through the official Sanofi Careers portal using the application link above. |
9. Disclaimer
Job details are based on the official Sanofi vacancy and may change or close without notice. Please check the official Sanofi Careers page for the latest information before applying. Pharma Career Updates is not the employer or recruiter for this position.
