Sanofi Hiring for Medical Regulatory Writer
Join Sanofi Business Operations and make an impact in the pharmaceutical industry as a Medical Regulatory Writer. Contribute to high-quality regulatory documentation while supporting global business units, including Specialty Care, Vaccines, General Medicines, and more. Sanofi Hiring for Medical Regulatory Writer
Job Details
- Position: Medical Regulatory Writer
- Location: Hyderabad
- Experience: Minimum 2 years in regulatory writing
- Salary: ₹6 – ₹12.5 LPA
- Qualifications:
- Required: PhD, B.Sc, M.Sc, M.Pharm, Pharm.D, B.Pharm, MBBS, BDS, BAMS, BHMS, or MD
About Sanofi Business Operations
Sanofi Business Operations is a strategic organization that provides centralized services to enhance Medical, HEVA, and Commercial operations globally. It supports various divisions, including R&D, Vaccines, Data & Digital functions, and more, focusing on innovation and quality. Sanofi Hiring for Medical Regulatory Writer
Main Responsibilities
As a Medical Regulatory Writer, your responsibilities include:
Document Development
- Author and edit medical sections for:
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Addendums to clinical overviews
- Disease and Product ID Cards
- Product alerts and trial transparency documents
- Deliver high-quality, compliant regulatory content.
Collaboration
- Work with Scientific Communication, Medical Regulatory Writing, Pharmacovigilance, and Regulatory Affairs teams.
- Build strong relationships with stakeholders within allocated business units and product areas.
Content and Process Management
- Post and track documents on platforms like CTG, EUCTR, and EUDRACT.
- Support the implementation of annual medical regulatory plans.
- Ensure audit-readiness and compliance with Sanofi quality standards.
Expertise Development
- Gain deep knowledge of Therapeutic Areas (TAs).
- Participate in planning data analyses and presentations under guidance.
Skills and Qualifications
Experience
- Over 2 years of regulatory writing experience in the pharmaceutical or healthcare industry.
Technical Skills
- Proficiency in medical writing, editing, and summarizing scientific information.
- Knowledge of ICH guidelines, GCP/GVP, and regulatory requirements.
- Skills in data retrieval, scientific interpretation, and medical literature screening.
Soft Skills
- Strong stakeholder and vendor management abilities.
- Excellent communication skills, both verbal and written.
- Ability to work independently and as part of a team.
Education
- Advanced degrees in Life Sciences, Pharmacy, or related fields (e.g., PhD, M.Pharm, M.Sc).
- Medical degrees like MBBS, BDS, BAMS, BHMS, or MD are also eligible.
Language Proficiency
- Fluent in English (reading, writing, and speaking).
Why Join Sanofi?
Sanofi values work-life balance, flexibility, and career growth. This role offers an opportunity to contribute to global healthcare outcomes while working with cutting-edge regulatory processes.
Apply online now and become a part of a world-class organization dedicated to innovation and quality! Sanofi Hiring for Medical Regulatory Writer
More Jobs
Sarkari Jobs
Leave a Comment