Biotechnology Jobs at Amgen | BSc/MSc Graduates Apply Now for the Regulatory Affairs Associate Role
Amgen is hiring a Regulatory Affairs Senior Associate (On-Site, Hyderabad, India) to support its Regulatory CMC Compliance team. In this role, you will help ensure Amgen’s innovative therapies meet global regulatory requirements by maintaining state and federal licenses, preparing submissions, and partnering with cross-functional teams. This is an opportunity to join a world leader in biotechnology, contribute to the development of life-saving medicines, and expand your expertise in regulatory affairs within a collaborative, patient-focused environment.
- Job Title: Regulatory Affairs Sr Associate
- Location: Hyderabad, India
- Job ID: R-224599
- Career Category: Regulatory
About the Company
Amgen is a global biotechnology company dedicated to improving the quality of life for people worldwide. We foster an inclusive environment of diverse, ethical, committed, and highly accomplished individuals who work together to advance science in the fight against serious diseases.
Job Description
The Senior Associate in Regulatory Affairs at Amgen plays a crucial role in ensuring that the company’s products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with
applicable regulations.About The Regulatory Compliance Team
The Regulatory Compliance team within Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC), facilitates product development and global registration by developing and executing regulatory strategies. The team is currently seeking to expand its capacity in India by assessing operational changes for regulatory reportability and maintaining state and federal licenses for Amgen products.
Roles & Responsibilities
- Track license status to ensure all are current and effective
- Communicate requirements to internal teams
- Obtain supplemental documentation from partners
- Prepare, review, and submit license applications and renewals
- Maintain all State Licensing documentation and interactions with relevant authorities
- Interface with regulatory bodies such as the State Board of Pharmacy and the Department of Health
- Complete required annual notifications to the FDA
Basic Qualifications:
- Master’s degree OR Bachelor’s degree and 2 years of regulatory CMC experience OR Associate’s degree and 6 years of experience in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
- Degree in the Life Science discipline
- Regulatory CMC-specific knowledge & experience
- Experience in the pharmaceutical/biotech industry
- Working knowledge of US state and federal licensing requirements
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