GRA Labelling Group Lead

Sanofi
Full Time • Hybrid
₹15 Lakhs - ₹20 Lakhs
Hyderabad
Posted 13h ago

GRA Labelling Group Lead

Sanofi

Job description

Seeking a leadership position in regulatory affairs and pharmaceutical labeling? Sanofi, Hyderabad, is looking for a GRA Labeling Group Lead.

 Company Description 

Sanofi is a healthcare and biopharmaceutical corporation dedicated to transforming the practice of medicine and patient outcomes through research and development. Working at Sanofi involves projects aimed at meeting patient needs and innovating in healthcare, with employees cooperating across scientific and functional teams.

 Position Summary 

The GRA Labeling Group Lead is a senior regulatory leadership role based in Hyderabad with a mixed working approach. The role will provide leadership to labelling strategists, manage team performance and development, organize resources and ensure timely delivery of high quality labelling work. The role also includes giving strategic advice across a broad product portfolio, supporting regulatory submissions and complex labeling efforts, and offering guidance on corporate labelling papers such as CCDS, US, EU and WHO materials.

 Key Responsibilities 

  • Manage the recruiting, onboarding, training, coaching, and performance management of labelling team members.

  • Define team competencies, identify skill gaps, and build plans to improve individual capabilities.

  • Establish backup and contingency coverage to continue product and project support.

  • Use dashboards, trackers and portfolio management tools to monitor the growth of a broad product portfolio.

  • Set KPI’s for quality and delivery, including submission timelines, deviations/errors and cycle durations and monitor.

  • Apply project and portfolio management discipline to balance competing priorities across the product portfolio.

  • Lead labeling strategists in development and/or update of corporate labeling papers such as CCDS, US, EU, WHO documents and associated patient booklets.

  • Manage the full labeling review and approval process from start to finish, including the preparation of submission elements, communications with health authorities, negotiations, approvals and the dissemination of the final labeling.

  • Support development items, marketed products, lifecycle-management operations, line extensions, and other complicated labeling tasks.

  • Position the team to be a labeling subject matter expert for cross functional teams and support global regulatory strategies.

  • Lead multidisciplinary labeling working groups, present labeling proposals, develop consensus and support submissions to the Labeling Governance Committee.

  • Provide strategic direction and oversight on complicated labeling initiatives; provide guidance to team members as needed.

  • Identify portfolio risks and potential implementation issues and assist with management to mitigate impact.

  • Direct the review of study reports, post-marketing pharmacovigilance information and other scientific data used to support labeling suggestions.

  • Perform sophisticated competitor and comparison label analysis to derive regulatory and strategic insights.

  • Ensure that labeling deliverables are completed on schedule and satisfy quality expectations.

  • Mentor junior labeling professionals in CCDS, EU and US requirements and how to apply regulatory guidelines to labeling text

  • Lead cross-functional process improvement projects, including labeling and larger GRA themes.

  • Interpret and apply the requirements of agencies such as FDA, EMA and other health authorities.


Educational Qualification  

Physician, Pharmacist, Veterinarian or Life Sciences.

 Required Skills 

  • Relevant regulatory affairs and pharmaceutical labeling experience.

  • Strong knowledge of drug labeling requirements including CCDS, EU and US advice and legislation.

  • Understanding of the regulatory requirements for marketing-authorisation submissions for new and marketed products.

  • Experience in linking labeling strategy to the wider regulatory approach.

  • Strong leadership and personnel management skills.

  • Leadership of matrix teams, negotiate complex issues, manage stakeholders and build consensus.

  • Strong knowledge of end to end labeling process and experience working across Regulatory, Medical Affairs, Pharmacovigilance, Quality and Supply Chain.

  • Excellent verbal and written communication abilities.

  • Strong analytical, organizational, project management, problem solving and critical thinking skills.

  • Experience with document-management and labeling systems such as Veeva Vault, EDMS and RIM systems and text verification and quality control tools.

  • Ability to expand scientific knowledge across disciplines such as statistics and disease areas.

  • Excellent networking and stakeholder coordinating capabilities.

  • Ability to collaborate well with colleagues and management across home and abroad teams.

 Salary  

The average salary for a GRA Labeling Group Lead is between ₹15 Lakhs-20 Lakhs per year in India.

 Career Progression 

This post is an opportunity to build leadership, regulatory strategy, global labelling, stakeholder management and portfolio-management skills working with diverse and international teams at Sanofi.

 How To Apply 

  • Search for the GRA Labeling Group Lead on our portal.

  • Click on the position to see the whole job description.

  • Fill out your information and upload your resume.

  • Submit your application.

Employment Type: Full Time • Hybrid
Industry: Healthcare
Role Category: Doctors
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

DoctorsPharmacyDentistNon Clinical JobsPhysiotherapy

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

Jobslly curates specialized corporate healthcare listings tailored for medical graduates seeking a career pivot. Instead of sifting through general medical job boards, doctors can use our platform to directly access high-paying non-clinical opportunities in Pharmacovigilance, Medical Writing, and Clinical Trial Management with top pharmaceutical companies and CROs. Most MBBS/BDS grads don't realise — clinical background is already enough to get into pharma. The problem is nobody explains this clearly. On Jobslly each listing shows salary range, fresher eligibility, and certifications worth getting before applying. Pharmacovigilance roles for example keep asking for RQAP-GCP. All this is on the listing itself, no separate research needed.
Yes. Jobslly features dedicated filtering for remote and hybrid healthcare roles, which are highly sought after by medical professionals looking for better work-life balance. Doctors can easily track and apply for verified work from home positions, such as Telehealth Consultants, Medical Chart Reviewers, and Drug Safety Associates, directly through the platform Real problem with remote medical jobs — half are fake, half are badly described. You join and realise it's a night shift for a US team nobody mentioned. Jobslly listings show shift timings, contract type, whether company gives equipment or WFH allowance. All upfront before you apply.
Generic job portals often bury specialized clinical roles under thousands of unrelated listings. Jobslly is purpose-built exclusively for the healthcare and health-tech sectors. We provide doctors with targeted career alerts for niche specialties, direct application routes to premium employers in major hubs like Mumbai and Bangalore, and real-time insights into medical salary benchmarks. Salary benchmark is something doctors switching careers genuinely need. No idea what number to quote, quote low, stuck with it forever. Jobslly shows pay ranges — by role, city, experience level. Career alerts are filtered by specialty and location so inbox isn't flooded with irrelevant stuff daily.
To protect medical professionals from recruitment fraud and unverified agencies, Jobslly operates a strictly vetted ecosystem. We exclusively partner with verified employers, prioritizing NABH-accredited hospitals, established health-tech innovators, and recognized multinational pharma brands so you can apply with complete confidence. Fake agencies, ghost listings, upfront fee scams — very common in medical recruitment, especially pharma and international roles. Jobslly doesn't allow unregistered agents on platform at all. Each listing shows actual audit date, not just an old generic verified badge. Suspicious listing — report button is there, compliance checks within 24 hours.
Yes. Backed by the Academically Global network, Jobslly goes beyond domestic job listings by providing access to structured International Placement Programs. We connect ambitious doctors, nurses, and clinical staff with credible, high-paying healthcare contracts in global markets like the UK, Australia, and the UAE, while outlining the necessary credentialing steps. UK needs PLAB, Australia needs AMC, UAE needs DHA or HAAD depending on emirate. Most doctors know this but the full picture — exam pattern, timeline, cost, official links — is scattered everywhere. Jobslly puts the credentialing roadmap directly on each international listing. Academically Global counsellors also available — people who've actually placed Indian doctors in these countries, know exactly where candidates get stuck.
Forget the assumption that only senior doctors make the big money. That's outdated. Right now, some of the best packages in Indian healthcare are going to people you wouldn't expect — Senior Medical Writers, Clinical Data Managers, Pharmacovigilance Specialists working with global pharma firms or CROs. These aren't rare unicorn jobs. They exist, they hire regularly, and the salaries are negotiable in ways hospital jobs rarely are. Most candidates just don't know to look for them.
Not all cities are equal on this front, and applying blindly wastes time. Bangalore is where health-tech and clinical research hiring is concentrated. Hyderabad is pharma country – manufacturing, QC, formulation, R&D. Mumbai and Navi Mumbai handle specialized hospital care, advanced nursing roles, and pharmacovigilance admin, medical writing, policy work all coexist there without one dominating the other. If you're open to relocating, knowing this upfront changes which jobs you even bother applying for.
Both. That's the honest answer. Legitimate remote roles in healthcare have existed long before anyone started calling things "hybrid." Medical Coders, Pharmacovigilance Associates, Telehealth Coordinators, Freelance Medical Writers — these positions have been hiring remotely for years through companies that are very much real. The fake ones almost always have one thing in common: they ask for money. Registration fees, document processing charges, security deposits — whatever the label, it's a scam. No actual employer takes money from a candidate before they join. That rule holds without exception.
EMR platforms, digital documentation tools, data tracking systems, AI-assisted reporting software. These aren’t “nice to have” anymore. They’re baseline. Clinical Knowledge is still the foundation but walking into an interview unable to navigate the systems the team uses daily is a problem. Candidates who are already familiar with these tools don’t need to be trained from scratch, and that matters when hiring managers are comparing two otherwise similar profiles.
Short answer: yes, and it's happening constantly. Long answer: it depends on what you want. If structured hours, no emergency calls, and a salary that doesn't plateau after three years sound appealing — corporate healthcare is worth your attention. Medical Writing, Drug Safety Review, Insurance Auditing, Health-tech Program Management — these roles specifically want people who understand clinical realities. A nursing degree or MBBS isn't a handicap here. It's often the reason you get the interview.