Job Title: Senior Medical Regulatory Writer
Hiring Manager: Head Scientific Communications / Team Lead
Location: Hyderabad
% of Travel Expected: As per business needs
Job Type: Permanent, Full-time
Company: Sanofi
Department: Sanofi Business Operations
About the Job
As a Senior Medical Regulatory Writer at Sanofi’s Hyderabad location, you will be responsible for creating high-quality, compliant medical and regulatory documents, supporting global teams across various therapeutic areas. This role demands strong domain knowledge, medical writing skills, and cross-functional collaboration. You’ll contribute to vital medical communication needs and play a key role in ensuring timely and accurate documentation in line with regulatory standards.
Main Responsibilities
Document Writing & Review
Write/edit high-quality regulatory documents:
Periodic Benefit-Risk Evaluation Reports (PBRER)
Clinical Study Reports (CSR)
Addendum to Clinical Overviews (ACO)
Clinical Evaluation Reports
Disease/Product ID Cards
Product Alerts, Trial Transparency Documents
Ensure timely delivery and compliance with internal and external standards.
Review content developed by peers, mentor junior writers, and act as an expert resource.
Planning & Collaboration
Participate in planning analyses and data presentations.
Collaborate with Scientific Communications, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams.
Maintain and expand expertise in assigned Therapeutic Areas (TAs).
People & Stakeholder Engagement
Develop effective relationships with key stakeholders in global business units and pharmacovigilance departments.
Support and mentor other regulatory writers.
Performance & Process Management
Deliver medical documents as per timelines and quality standards.
Maintain regulatory requirements across supported countries.
Conduct writing needs analysis and implement yearly regulatory plans.
Liaise with vendors and manage deliverables.
Track and archive regulatory materials, ensuring inspection-readiness.
Stay current with Sanofi's evolving policies and quality standards.
Stakeholder Interaction
Collaborate with medical, regulatory, legal, and pharmacovigilance stakeholders to create tailored content.
Prepare standby statements and Q&A documents for product alerts.
About You
Experience
Minimum 5 years of experience in regulatory writing within the pharmaceutical or healthcare industry.
Education
Advanced degree in Life Sciences, Pharmacy, or similar (PhD, Master’s, Bachelor’s, D Pharma, PharmD, MBBS, BDS, BAMS, BHMS, MD)
Technical Skills
Excellent medical writing and editing skills
Expertise in ICH/GCP/GVP guidelines
Scientific data interpretation, literature screening
Proficient in tools for medical writing and documentation management
Soft Skills
Strong communication and stakeholder management
Vendor coordination
Independent and team-based working capability
Languages
Excellent written and spoken English
Company Values
Sanofi embraces diversity and inclusion, offering equal opportunities regardless of background, gender, or orientation. Be part of a global organization driven by the mission to pursue progress and discover the extraordinary.
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