Submission Manager

At Novartis, we are dedicated to transforming the lives of patients through innovative pharmaceuticals and cutting-edge technologies. As a global leader in the healthcare industry, we are seeking a highly organized and detail-oriented Submission Manager to join our team. In this role, you will be responsible for managing the submission process for new drugs and therapies, ensuring compliance with regulatory requirements and timelines. The ideal candidate will have a strong understanding of drug development and regulatory affairs, exceptional project management skills, and a passion for improving patient outcomes. If you are ready to make a meaningful impact in the pharmaceutical industry, we encourage you to apply for our Submission Manager position.

1. Manage the submission process for new drugs and therapies to regulatory authorities, including but not limited to FDA, EMA, and other global agencies.
2. Ensure compliance with all relevant regulatory requirements, guidelines, and timelines.
3. Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Development, Medical Affairs, and Quality Assurance, to gather necessary information and documents for submissions.
4. Develop and maintain submission timelines, track progress, and communicate any potential delays or issues to stakeholders.
5. Serve as the primary point of contact for regulatory agencies during the submission process and respond to any inquiries or requests for additional information.
6. Stay up-to-date on changes in regulations and guidelines related to drug development and submission processes.
7. Closely monitor submission activities and provide regular updates to management regarding project status, risks, and mitigation plans.
8. Ensure all submission documents are complete, accurate, and of high quality, adhering to company standards and industry best practices.
9. Develop and maintain submission-related templates, processes, and procedures to streamline and improve efficiency.
10. Contribute to the development of regulatory strategies and provide input on potential risks or issues related to submissions.
11. Manage and maintain the electronic document management system for submissions, ensuring all documents are appropriately filed and version-controlled.
12. Participate in internal and external audits and inspections related to submissions and provide necessary support and follow-up actions.
13. Provide guidance and support to junior team members and assist with their professional development.
14. Act as a subject matter expert in submission-related matters and provide training to cross-functional teams as needed.
15. Continuously evaluate and improve submission processes and systems to ensure compliance and efficiency.

According to JobzMall, the average salary range for a Submission Manager in Hyderabad, Telangana, India is between ₹400,000-₹800,000 per year. This can vary depending on the company, industry, and level of experience of the individual. Some factors that can also impact salary include education level, certifications, 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.