Attention Job Seekers: Medical Regulatory Writing Opportunity at Sanofi, Hyderabad! Apply Now!

Medical Regulatory Writer Job at Sanofi, Apply Now!

Are you passionate about transforming complex scientific data into high-quality regulatory documents? Sanofi is seeking an experienced Medical Regulatory Writer to join our team in Hyderabad, India. In this role, you will develop and deliver high-quality safety documents, Periodic Benefit-Risk Evaluation Reports (PBRER), Addendum to Clinical Overviews (ACO), and other regulatory documents, ensuring compliance with global standards and regulatory requirements. If you have a keen eye for detail and strong expertise in regulatory writing, this position is a great opportunity to contribute to global healthcare innovation.

Key Responsibilities:

• Document Development:

  • Write, edit, and review high-quality safety documents, including:
    • Periodic Benefit-Risk Evaluation Reports (PBRER)
    • Addendum to Clinical Overviews (ACO)
    • Disease and Product ID Cards
    • Product alerts and trial transparency documents
  • Ensure compliance with internal and external regulatory standards while delivering documents on time.

• Collaboration & Stakeholder Management:

  • Work closely with global Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, Regulatory, and Corporate Affairs teams.
  • Engage with clinical/medical teams to identify writing needs and customize deliverables as per region-specific requirements.

• Process & Compliance:

  • Conduct needs analysis for medical regulatory writing and implement relevant elements of the regulatory plan.
  • Manage and track postings on platforms such as CTG (ClinicalTrials.gov), EUCTR, and EUDRACT.
  • Assist with product alerts by preparing/reviewing Stand-By Statements (SBS) and Questions & Answers (QA) documents.
  • Ensure all processes comply with Sanofi’s policies and maintain audit and inspection readiness.

Required Qualifications for Medical Regulatory Writer Job:

Experience:

• Minimum 2 years of experience in regulatory writing for the pharmaceutical or healthcare industry.

Education:

• Advanced degree in Life Sciences/Pharmacy or related fields (PhD, Master’s, or Bachelor’s in Science, D Pharma, PharmD)
• Medical degrees such as MBBS, BDS, BAMS, BHMS, or MD are also accepted.

Technical Skills:

• Strong knowledge of ICH and GCP/GVP guidelines.
• Proficiency in medical writing, scientific data interpretation, and regulatory standards.
• Expertise in time management, risk management, and document review.

Soft Skills:

• Strong stakeholder and vendor management skills.
• Excellent communication skills and ability to work independently or within a team environment.

Languages:

• Excellent proficiency in English (reading, writing, and speaking).

APPLY ONLINE HERE

Keywords: Medical Regulatory Writer, Sanofi, Hyderabad, Pharmaceutical, Healthcare, Regulatory Writing