Subject Matter Expert - Regulatory Affairs and Medical Writing
Subject Matter Expert - Regulatory Affairs and Medical Writing
Cognizant
Job description
Cognizant is hiring a Regulatory Affairs and Medical Writing Subject Matter Expert in Mumbai, offering a great hybrid career opportunity for life science professionals.
Company Description
Cognizant is a company that builds AI and provides technology services. The company helps companies turn their AI investment into business value by creating full-stack AI solutions. Cognizant’s deep knowledge of industry, process, and engineering helps clients stay ahead in a changing world. With more than 350,000 people worldwide, Cognizant offers wide career paths and strong learning support.
Job Summary
This position is for a Subject Matter Expert in Regulatory Affairs and Medical Writing in Mumbai. The SME will use regulatory knowledge to write clear, compliant documents for life sciences projects, improve processes, and collaborate with global teams. No travel is needed. A RAC certification is preferred.
Key Responsibilities
Work with teams and research teams to build documentation plans that meet global rules.
Prepare submissions using Veeva and other approved tools with accurate tracking.
Write accurate documents, such as clinical overviews, summaries, and technical narratives.
Turn research insights into clear product documents that explain product use and risks.
Review regulatory process documents to keep them consistent, traceable, and complete across the product life cycle.
Give expert advice on compliance so medical writing matches the data.
Track timelines and plan writing tasks so every document meets submission dates.
Suggest ways to improve data consistency, version control, and audit readiness.
Educational Qualification
A bachelor's or master's degree in pharmacy, life sciences, or a related field is usually expected.
A Regulatory Affairs certification such as RAC, or an equal life sciences regulatory credential, is preferred.
Skills Required
Strong regulatory domain knowledge and hands-on experience with life sciences regulatory documents.
Skill with Veeva for document workflows, version control, and inspection-ready records.
Experience as a regulatory product specialist who writes clear product documents.
Ability to turn business needs into detailed regulatory documents, like a regulatory business analyst.
Deep understanding of regulatory rules and standards.
Experience with regulatory business process work and process improvement.
Strong written English and clear communication.
Salary Structure
The average salary for a Subject Matter Expert (SME) in Regulatory Affairs and Medical Writing at Cognizant in India generally ranges from ₹6 Lakhs to ₹7.5 Lakhs per year.
Career Development
This role builds strong skills in regulatory affairs and medical writing within a large global technology company. It can help you grow into a senior regulatory lead or wider life sciences consulting role over time.
How to Apply
Visit our job portal and search for the SME Regulatory Affairs and Medical Writing role in Cognizant, Mumbai.
Open the job listing and read through the full details.
Fill in your profile and upload your latest resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
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.