Senior Medical Regulatory Writer

Welcome to Sanofi, a leading global pharmaceutical company dedicated to improving the lives of patients around the world. We are seeking a highly experienced and talented Senior Medical Regulatory Writer to join our team and play a key role in bringing life-changing medicines to market.As a Senior Medical Regulatory Writer, you will have the opportunity to collaborate with cross-functional teams to develop high-quality regulatory submissions for our innovative products. Your expertise in medical writing and regulatory requirements will be critical in ensuring the successful approval and launch of our medicines.We are looking for a passionate and driven individual who is committed to upholding the highest standards of quality and compliance in their work. If you have a strong background in medical writing, a deep understanding of regulatory guidelines, and a desire to make a positive impact on patients' lives, we want to hear from you. Join us in our mission to make a difference in the world of healthcare.

1. Collaborate with cross-functional teams to develop high-quality regulatory submissions for innovative products.
2. Ensure all regulatory documents are written in compliance with company and regulatory guidelines.
3. Conduct thorough research and analysis to support the development of regulatory submissions.
4. Review and edit documents written by other team members to ensure accuracy and consistency.
5. Stay up-to-date with changes in regulatory guidelines and requirements.
6. Communicate effectively with internal and external stakeholders regarding regulatory writing and submissions.
7. Provide guidance and mentorship to junior medical writers.
8. Ensure all documents are completed within established timelines and meet regulatory deadlines.
9. Maintain a high level of quality and accuracy in all written materials.
10. Participate in regulatory authority meetings and support the preparation of briefing documents.
11. Act as a subject matter expert in medical writing and regulatory requirements.
12. Collaborate with regulatory affairs, clinical, and preclinical teams to ensure alignment and consistency in messaging.
13. Conduct QC checks and ensure all documents are in compliance with company and industry standards.
14. Assist in the development and implementation of standard operating procedures for medical writing.
15. Continuously strive for process improvement and identify ways to streamline the regulatory writing process.

According to JobzMall, the average salary range for a Senior Medical Regulatory Writer in Hyderabad, Telangana, India is between ₹8,00,000 and ₹12,00,000 per year. This equates to approximately $11,000 to $16,500 in USD. However, salaries may vary depending on the specific company, experience level, and other factors.

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.