Life Sciences BSc Regulatory Affairs Jobs at Amgen – Apply Now
Are you a life science graduate and looking to advance your career in regulatory affairs? Amgen, a global biotechnology leader, is hiring a Sr. Associate in Regulatory Affairs at its Hyderabad location. This on-site role offers an exciting opportunity to contribute to Chemistry, Manufacturing, and Controls (RA CMC) submission execution, supporting innovative therapies and devices that help millions of patients worldwide. If you have the right qualifications and a passion for regulatory excellence, this could be the perfect career move for you.
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 Title: Sr. Associate Regulatory Affairs
- Job ID: R-224555
- Location: Hyderabad
- Category: Regulatory
Job Description:
Amgen’s Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) team is seeking a Senior Associate to join the Regulatory Optimization of Tactical and Strategic Support (ROOTS2) team in India. The ROOTS2 team supports
product development and global registration by developing and executing regulatory strategies. The ideal candidate will lead submission activities, interact with subject matter experts, and document CMC submissions.Responsibilities:
- Lead various submission activities
- Interact with authors and reviewers
- Prepare submission content plans
- Coordinate country-specific documents
- Document and archive submissions
- Maintain product timelines
- Train staff on procedures and systems
- Provide status reports on projects
- Participate in special project teams
Basic Qualifications:
- Master’s degree OR Bachelor’s degree and 1-2 years of experience
- Associate’s degree and 6 years of experience
Preferred Qualifications:
- BS degree in Life Science
- Experience in manufacturing or quality control
- Regulatory CMC specific knowledge
- Project management and organizational skills
- Strong communication skills
Keywords: Associate Regulatory Affairs Job, Life Science, Regulatory Affairs, CMC, India, Hyderabad, Pharmaceutical, Biotechnology, Amgen, Life Sciences BSc Regulatory Affairs Jobs at Amgen – Apply Now
