Amgen Regulatory Affairs Job – Apply Now!
Looking for a Regulatory Affairs job in Hyderabad? Amgen, a global biotechnology leader, is hiring a Sr. Associate in Regulatory Affairs to support CMC regulatory strategies and global submissions. If you have experience in regulatory submissions, CMC documentation, and cross-functional collaboration, apply today to join a Fortune 500 company dedicated to scientific innovation and patient care.
About Amgen
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
Job Opening: Sr. Associate Regulatory Affairs
JOB ID: R-205856
LOCATION: India – Hyderabad
WORK LOCATION TYPE: On Site
CATEGORY: Regulatory
Job Description:
Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or
activities that impact a product.Additional Responsibilities for Amgen Regulatory Affairs Job:
- Lead submission for various regulatory documents
- Interact with authors, reviewers, and subject matter experts
- Prepare submission content plans
- Coordinate collection of CMC country-specific documents
- Document and archive submissions
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Participate in cross-functional special project teams
Basic Qualifications for Amgen Regulatory Affairs Job:
- Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
- Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry.
Preferred Qualifications for Amgen Regulatory Affairs Job:
- BS degree in Life Science
- Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
Why Join Amgen?
- Work with a global leader in biotechnology
- Contribute to regulatory strategies for life-saving medicines
- Collaborate with cross-functional regulatory teams
- Career growth opportunities in a Fortune 500 company
Keywords: Amgen, Sr. Associate Regulatory Affairs, Regulatory Affairs, CMC submission execution team
