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Full Time

Senior Medical Regulatory Writer

Sanofi
Hyderabad
₹21 LPA - ₹23.4 LPA
Posted 27/06/2026

About the Role

Company Overview

Sanofi is a health-care organization that uses scientific knowledge to enhance lives of people. It operates in different therapeutic segments and tries to provide patients with improved drugs and treatment outcomes. The Business Operations division is supposed to make operations within the organization more effective because of simplifying, accelerating, and optimizing processes. Having global offices, one of which is located in Hyderabad, India, Sanofi gathers professionals who can contribute with their experience, work digitally, and innovate.

Job Summary

The Senior Medical Regulatory Writer is responsible for creating and reviewing important clinical and safety documents. These documents support:

  • Regulatory submissions

  • Safety reporting

  • Clinical research activities

Responsibilities include drafting medically accurate content while adhering to all regulatory guidelines. The person will work alone on any assignment and also help other team members in review and knowledge sharing.

The job entails scientific knowledge, excellent writing skills, time management, and task management skills. The person will also be collaborating with teams from different departments:

  • Medical

  • Pharmacovigilance

  • Regulatory

  • Clinical

Key Responsibilities

Medical Writing and Documentation

  • Write and edit high-quality clinical and safety documents

  • Prepare documents such as Periodic Benefit-Risk Evaluation Reports (PBRER), Addendum to Clinical Overviews (ACO), and Clinical Study Reports (CSR)

  • Develop Product and Disease ID Cards and clinical evaluation reports

  • Create product alerts and trial transparency documents

  • Ensure all documents are clear, accurate, and scientifically strong

Planning and Data Analysis

  • Participate in planning how data will be analyzed and presented

  • Work with senior or mentoring writers when required

  • Understand and organize complex clinical and safety data

  • Present data in a simple and structured way

Quality Review and Peer Support

  • Review documents created by other writers

  • Give constructive criticism for better quality and clarity of the content

  • Mentor or buddy up junior authors

  • Share knowledge and best practices within the team

Collaboration with Teams

  • Collaborate with teams dealing with:

  • Scientific communications

  • Regulatory writing, and

  • Pharmacovigilance

  • Coordinate with clinical, regulatory, and corporate affairs teams

  • Talk with stakeholders to understand requirements

  • Maintain effective teamwork among global/local teams

Stakeholder Management

  • Build and maintain good relationships with medical and scientific stakeholders

  • Work with pharmacovigilance and regulatory teams to meet project needs

  • Understand stakeholder expectations and deliver customized documents

  • Support team members by sharing expertise and guidance

Regulatory Compliance and Process Management

  • Ensure all documents follow regulatory guidelines such as ICH, GCP, and GVP

  • Stay updated with company policies and regulatory changes

  • Support medical regulatory planning activities

  • Follow defined processes for document creation and review

  • Ensure all work is audit-ready and properly documented

Deliverables and Performance

  • Deliver documents such as PBRER, ACO, CSR, and clinical evaluation reports on time

  • Prepare briefing packages and medical sections of Clinical Trial Applications (CTA)

  • Manage product alerts and prepare related documents like standby statements and Q&A

  • Support posting of clinical trial information on platforms like ClinicalTrials.gov (CTG), EUCTR, and EUDRACT

  • Ensure all deliverables meet quality and timeline expectations

Process Improvement and Documentation

  • Identify ways to improve writing processes and workflows

  • Work with vendors to deliver projects as per defined processes

  • Track and manage document submissions and archiving

  • Ensure all documents are properly filed and stored in systems

  • Use feedback to improve content and delivery methods

Education and Professional Qualifications

Educational Background

  • MBBS

  • PharmD

  • M.sc, or

  • Advanced degree in related fields

Professional Experience

  • 5 years of experience in medical regulatory writing in pharmaceuticals or healthcare organizations.

  • Experience in clinical and safety documentation.

Technical Competencies

The role demands expertise in:

  • Medical writing and editing

  • Knowledge of regulatory guidelines (ICH, GCP, GVP)

  • Understand and summarize data

Familiarity with:

  • Clinical documentation

  • Reporting system

Analytical ability and a keen eye to interpret and present complex data.

Should also have good skills with computers and experience with document management systems.

Soft Skills

  • Effective communication

  • Teamwork ability

  • Works independently as well as collaborates in a team

  • Time management

  • Eye for detail

  • Problem-solving ability

Language Proficiency

Excellent command over oral and written English.

Salary and Benefits

Sanofi offers a competitive pay package that matches industry norms. The salary bracket for the job is INR 21 – 23.4 LPA. There is room for negotiations depending on the candidate’s level of experience. Employees also enjoy:

  • Incentives based on performance

  • Medical benefits for oneself and the family

  • Conducive working conditions

The company offers constant training and career development programs for employees in a global context.

Importance of the Role

A Senior Medical Regulatory Writer ensures that clinical data is correctly written and presented. It is essential for informed decision-making on the part of regulatory agencies and healthcare practitioners. This position contributes directly to patient safety and success of clinical initiatives. It contributes significantly to maintaining quality and compliance in the company.

Career Progression Prospect

This role offers good career growth opportunities. With experience, individuals can move into roles such as

  • Principal Medical Writer

  • Regulatory Lead

  • Medical Affairs positions

Exposure to global projects and different therapeutic areas helps build strong expertise and career development.

How to Apply

Sanofi is one of the leading companies in medicine and healthcare. It is a long time goal for many healthcare graduates who are looking to work in projects having meaningful impact.

To apply:

  1. Create your account on Jobslly.

  2. Search for job  Senior Medical Regulatory Writer/ Sanofi

  3. Upload your resume, a brief cover letter explaining why you’re interested.

  4. Also upload any relevant portfolios or certifications or courses.

  5. Submit and track the status of your application through your profile.

Diversity and inclusion are part of Sanofi's core values. It does not discriminate based on any criterion like gender or religion. It encourages applications from all kinds of people. Sanofi believes in innovation and teamwork.

Jobslly helps you connect with many such high-paying opportunities in the healthcare sector. Connect to find more roles that match your preference.

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.

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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.