RA CMC Senior Manager

Are you a highly experienced and driven individual looking to take the next step in your career? Do you have a strong background in regulatory affairs with a focus on CMC? If so, we have an exciting opportunity for you as the RA CMC Senior Manager at Novartis.As a global pharmaceutical company, Novartis is dedicated to improving the lives of patients through innovative medicines and therapies. As the RA CMC Senior Manager, you will play a crucial role in ensuring the quality, safety, and efficacy of our products by overseeing the regulatory strategy and submissions for our CMC portfolio.We are seeking a candidate with a minimum of 8 years of experience in regulatory affairs, specifically in CMC. A strong understanding of global regulatory requirements and experience in leading cross-functional teams is essential for success in this role. Additionally, excellent communication, collaboration, and project management skills are crucial.If you are a self-motivated and results-driven individual with a passion for making a difference in the pharmaceutical industry, we encourage you to apply for this exciting opportunity at Novartis. Join our team and help us continue to deliver life-changing treatments to patients around the world.

1. Develop and execute regulatory strategies for CMC submissions to support the development, registration, and maintenance of pharmaceutical products.
2. Ensure compliance with global regulatory requirements and guidelines for CMC submissions.
3. Oversee and manage CMC-related regulatory submissions, including INDs, NDAs, BLAs, and variations.
4. Lead cross-functional teams to ensure timely and high-quality submissions that meet regulatory requirements.
5. Stay current with regulatory updates and changes in the CMC landscape and communicate potential impact to the organization.
6. Collaborate with internal teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure alignment and consistency in CMC regulatory strategy.
7. Prepare and review CMC sections of regulatory documents, such as briefing packages, responses to regulatory agency questions, and annual reports.
8. Act as the primary contact with regulatory agencies for CMC-related inquiries and submissions.
9. Provide regulatory guidance and support to internal stakeholders, including project teams, manufacturing sites, and global affiliates.
10. Mentor and train junior team members on CMC regulatory requirements and processes.
11. Proactively identify potential CMC regulatory issues and develop mitigation plans.
12. Manage and maintain all CMC-related regulatory documentation and ensure compliance with document retention policies.
13. Contribute to the development and implementation of CMC regulatory processes and procedures to improve efficiency and compliance.
14. Represent the company at relevant industry meetings and conferences to stay informed on industry trends and best practices.
15. Act as a subject matter expert for CMC regulatory affairs within the organization and provide guidance and support to other departments as needed.

According to JobzMall, the average salary range for a RA CMC Senior Manager in Hyderabad, Telangana, India is approximately ₹ 20,00,000 to ₹ 25,00,000 per annum. This can vary depending on the specific company, experience level, and skills of the individual.

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.