Associate Director Regulatory Writing

Welcome to Novartis! We are a leading global pharmaceutical company dedicated to transforming patient lives through scientific innovation. As an Associate Director of Regulatory Writing, you will play a crucial role in driving the success of our regulatory submissions and ensuring compliance with regulatory guidelines. We are looking for a highly skilled and motivated individual with a passion for regulatory writing and a strong understanding of global regulations and guidelines. If you are a strategic thinker with excellent communication and project management skills, we invite you to join our dynamic team and make a meaningful impact on the healthcare industry.

1. Develop and implement regulatory writing strategies to support the successful submission of pharmaceutical products to regulatory authorities worldwide.
2. Ensure compliance with global regulatory guidelines and requirements throughout the development and submission process.
3. Collaborate with cross-functional teams to gather necessary information and data for regulatory submissions.
4. Write and edit regulatory documents, such as clinical study reports, protocols, and investigator brochures, in accordance with regulatory guidelines and company standards.
5. Review and provide feedback on documents prepared by other team members to ensure accuracy and consistency.
6. Serve as a subject matter expert on regulatory writing and provide guidance to internal stakeholders on best practices and regulations.
7. Track and manage timelines for regulatory submissions and provide regular updates to team members and management.
8. Stay informed of changes in regulatory requirements and communicate updates to relevant team members.
9. Participate in regulatory agency meetings and contribute to the preparation of meeting materials.
10. Collaborate with external vendors and contractors to ensure timely and accurate completion of writing projects.
11. Mentor and train junior team members on regulatory writing processes and best practices.
12. Continuously improve processes and procedures related to regulatory writing to increase efficiency and quality.

According to JobzMall, the average salary range for a Associate Director Regulatory Writing in East Hanover, NJ, USA is $120,000 to $150,000 per year. This salary range may vary depending on factors such as experience, education, and specific job responsibilities.

Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.