Regulatory Affairs Senior Manager (CMC)

Welcome to Amgen, a leading biotechnology company dedicated to discovering and developing innovative therapies for patients around the world. We are currently seeking a highly motivated and experienced Regulatory Affairs Senior Manager (CMC) to join our team. In this role, you will play a critical role in ensuring compliance with regulatory requirements and driving the successful development and approval of our pipeline products. As a key member of our Regulatory Affairs team, you will have the opportunity to make a significant impact on the lives of patients and contribute to our mission of advancing science and improving lives. To excel in this role, you should have a strong background in regulatory affairs, specifically in the CMC (Chemistry, Manufacturing, and Controls) space, and possess excellent communication and leadership skills. If you are passionate about making a difference in the healthcare industry and thrive in a fast-paced, dynamic environment, we encourage you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies for the successful development and approval of pipeline products in compliance with applicable laws and regulations.
2. Serve as the primary point of contact for all CMC-related regulatory activities.
3. Prepare and submit high-quality regulatory submissions, including INDs, NDAs, and amendments.
4. Review and analyze CMC data and documents to ensure accuracy and compliance with regulatory requirements.
5. Collaborate with cross-functional teams, including R&D, manufacturing, and quality, to ensure alignment and timely completion of regulatory activities.
6. Stay current on relevant regulations, guidelines, and industry trends to ensure compliance and drive continuous improvement.
7. Provide expertise and guidance on CMC regulatory requirements and potential risks to inform decision-making.
8. Represent the company in interactions with regulatory agencies, including pre-IND meetings, pre-NDA meetings, and FDA advisory committee meetings.
9. Lead and mentor junior regulatory affairs team members, providing guidance and support to ensure their development and success.
10. Participate in cross-functional initiatives and contribute to the development of company-wide policies and procedures related to regulatory affairs.
11. Proactively identify and address potential regulatory issues and challenges and develop mitigation strategies.
12. Foster a culture of compliance and continuous improvement within the organization.
13. Maintain accurate and up-to-date regulatory records and documentation.
14. Collaborate with global regulatory teams to ensure alignment and consistency across regions.
15. Communicate effectively with internal and external stakeholders, including senior management, partners, and regulatory agencies.

According to JobzMall, the average salary range for a Regulatory Affairs Senior Manager (CMC) in Hyderabad, Telangana, India is between ₹2,500,000 to ₹3,500,000 per year. This may vary depending on factors such as experience, education, and the specific company or industry.

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California.