Amgen is a global biotechnology pioneer that discovers, develops, and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep understanding of science, we strive to transform the promise of advanced science and technology into therapies that improve health outcomes and dramatically improve people’s lives.
At Amgen, we are committed to fostering an inclusive and collaborative work environment where every employee can thrive. Join us in our mission to serve patients and make a meaningful impact on the world.
Job Description
Amgen is seeking a Regulatory Compliance Change Assessor – Sr Associate to join our team in Hyderabad, India. This role is critical in ensuring regulatory compliance for product changes across Amgen’s global operations. The successful candidate will work closely with cross-functional teams, including Regulatory Affairs, Quality, Operations, and Supply Chain, to assess and document the impact of changes on product reportability and distribution restrictions.
Key Responsibilities
- Change Record Review:Â Evaluate change records to assess the impact of changes on product reportability and distribution restrictions.
- Regulatory Documentation:Â Define and document reporting and product distribution restriction requirements within the change control management system.
- Cross-Functional Collaboration:Â Liaise with Process Development, Operations, Quality, and Supply Chain teams to align regulatory strategies and ensure compliance.
- Global Compliance:Â Support global regulatory compliance efforts by ensuring changes meet all applicable regulatory requirements.
Qualifications
Basic Qualifications:
- Master’s degree in a relevant field OR
- Bachelor’s degree and 2 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- Associate’s degree and 6 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- Diploma and 8 years of experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
Preferred Qualifications:
- Degree in Life Sciences or a related discipline.
- Strong knowledge and experience in Regulatory CMC.
- Understanding of scientific/technical principles and their application in the pharmaceutical/biotech industry.
- Experience in manufacturing, testing (QC/QA or clinical), or distribution within the Pharmaceutical/Biotech industry.
Why Join Amgen?
- Impactful Work:Â Contribute to the development of life-saving therapies that improve patient outcomes worldwide.
- Career Growth:Â Access to professional development opportunities and a clear career progression path.
- Inclusive Culture:Â Be part of a diverse and inclusive workplace that values collaboration and innovation.
- Global Reach:Â Work with a global team and make a difference on an international scale.
