Apply Online for Medical Regulatory Writer at Sanofi

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people in over 100 countries at Sanofi are dedicated to making a difference on patients’ daily life, wherever they live and enabling them to enjoy a healthier life.

Post : Medical Regulatory Writer

Job Description
Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines.

Main responsibilities include
1) Participate with support in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
2) Develops and maintains TA expertise.
3) Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs teams based on the documents assigned.

People : 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.
2) Interact effectively with stakeholders in medical and pharmacovigilance departments.
3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.
• Performance : Provide deliverables (PBRER, ACO, Product and Disease ID Cards, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality.

Process :
1) Author, review, and act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
4) Work with selected vendors within the region to deliver the required deliverables as per the defined process.
5) Design an overall plan of action basis end-customers feedback & improve course content and delivery.
6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.
7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.
8) Remain abreast of Sanofi Policy or Quality Documents evolution.

Stakeholders :
1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables.

Candidate Profile
• Education : Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters or bachelor’s in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
• Experience : >2 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
• Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment.
• Technical skills : As applicable (including but not limited to time, and risk management skills, Excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications)
• Languages : Excellent English language knowledge (to read, write and speak)

Additional Information
Qualification : Advanced degree in life sciences/ pharmacy
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Regulatory
End Date : 30th August 2026