Expert Medical Regulatory Writer

Welcome to Sanofi, a leading pharmaceutical company focused on improving the health and well-being of people worldwide. We are currently seeking a highly skilled and experienced Expert Medical Regulatory Writer to join our team. In this role, you will play a critical role in ensuring the timely and accurate submission of regulatory documents, supporting the development and approval of life-saving medications. This is an exciting opportunity for someone with strong writing skills, attention to detail, and a deep understanding of medical regulations. If you are passionate about making a difference in the healthcare industry and have the necessary qualifications, we would love to hear from you.

1. Collaborate with cross-functional teams to gather and review data for regulatory submissions.
2. Write, edit, and proofread regulatory documents such as clinical study reports, protocols, and labeling documents.
3. Ensure compliance with all relevant regulations and guidelines in the development and submission of regulatory documents.
4. Coordinate and manage timelines and deliverables for multiple projects in a fast-paced environment.
5. Develop and maintain expertise in medical regulations and guidelines to ensure accuracy and consistency in writing.
6. Participate in meetings with regulatory agencies to present and defend regulatory documents.
7. Conduct thorough reviews and revisions of documents to ensure accuracy, clarity, and consistency.
8. Provide guidance and mentorship to junior writers on regulatory writing best practices.
9. Identify and implement process improvements to streamline regulatory writing processes.
10. Stay updated on industry trends and changes in regulations to ensure compliance and proactively address potential issues.
11. Collaborate with internal teams to ensure all documents are properly reviewed and approved before submission.
12. Maintain accurate and organized records of all regulatory documents and submissions.
13. Communicate effectively with internal and external stakeholders to address any questions or concerns related to regulatory documents.
14. Adhere to strict timelines and deadlines to ensure timely submission of regulatory documents.
15. Continuously review and improve writing processes and templates to ensure high-quality and efficient document preparation.

According to JobzMall, the average salary range for a Expert Medical Regulatory Writer in Hyderabad, Telangana, India is between ₹ 6,00,000-₹ 15,00,000 per year. This can vary depending on experience, education, and the specific company or organization the individual is working for. Some companies may also offer additional benefits such as bonuses, healthcare benefits, and other incentives.

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.