Job Opening: Medical Regulatory Writer at Sanofi Global Hub – Hyderabad, India

Sanofi is seeking a talented and detail-oriented Medical Regulatory Writer to join its growing team in Hyderabad, Telangana. If you’re passionate about regulatory science and medical writing, this is your chance to be a part of a global healthcare leader that’s transforming lives through innovation and data-driven healthcare solutions.

🏢 About Sanofi

Sanofi is a leading global healthcare company focused on human health. With a strong presence across Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital, Sanofi is committed to operational and analytical excellence to support Medical, HEVA, and Commercial teams worldwide.

📝 Role: Medical Regulatory Writer

Location: Hyderabad, Telangana, India
Employment Type: Full-Time

🔑 Key Responsibilities

• Write or edit high-quality regulatory and safety documents including:

  • Periodic Benefit-Risk Evaluation Reports (PBRER)

  • Addendum to Clinical Overview (ACO)

  • Disease and Product Identification Cards

  • Product Alerts and Trial Transparency Documents

• Collaborate with scientific, medical, pharmacovigilance, and regulatory teams across the globe.

• Ensure timely, compliant, and accurate delivery of all assigned documents.

• Participate in planning document content and data presentation with guidance from senior writers or mentors.

• Maintain therapeutic area (TA) expertise and stay updated with regulatory requirements and Sanofi policies.

• Track postings and ensure document readiness for audits or inspections on platforms such as:

  • ClinicalTrials.gov

  • EU Clinical Trial Register (EUCTR)

  • EudraCT

👥 Stakeholder Engagement

• Interact with medical experts, PV teams, and global business units to understand document requirements.

• Assist in needs analysis and development of the annual medical regulatory writing plan.

• Support other writers and share knowledge to enhance the team’s capabilities.

🎓 Qualifications & Experience

• Education: Advanced degree in Life Sciences or a medical field
  (PhD, MSc, BSc, PharmD, D Pharma, MBBS, BDS, BAMS, BHMS, MD)

• Experience: Minimum 2 years of experience in regulatory writing within the pharmaceutical or healthcare industry.

• Technical Skills:

  • Strong scientific writing and editing skills

  • Knowledge of ICH, GCP, and GVP guidelines

  • Familiarity with clinical trial documentation and databases

  • Ability to interpret scientific data and summarize effectively

• Soft Skills:

  • Excellent communication and time management

  • Strong collaboration and stakeholder management

  • Ability to work independently and within cross-functional teams

🌟 Why Join Sanofi?

• Be part of a globally recognized pharmaceutical organization.

• Contribute to life-changing therapies and ensure safety and transparency in healthcare.

• Work in a collaborative, diverse, and innovative environment.

• Expand your regulatory writing expertise and career growth opportunities.

📩 Apply now and take the next step in your regulatory writing journey with Sanofi in Hyderabad.

Empower health. Inspire hope. Write the future of medicine.

APPLY HERE