Amgen Hiring Global Regulatory Affairs and Safety Associate
Job Overview
Company: Amgen
Position: Global Regulatory Affairs and Safety Associate (GRAAS)
Location: Hyderabad, India
Experience: 0 – 7 Years
Education: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences
Application Mode: Online
About the Role
Amgen, a leading biotechnology company, is looking for a Global Regulatory Affairs and Safety Associate to join their team in Hyderabad. This role offers an exciting opportunity to contribute to clinical trial submissions, regulatory compliance, and global safety operations. Amgen Hiring Global Regulatory Affairs
Key Responsibilities
- Ensure compliance with EU Clinical Trials Regulation (EU CTR) for clinical trial submissions.
- Support EU Regulatory Lead in preparing Submission Content Plans and regulatory documentation.
- Perform Quality Control (QC) of data and documents before submission.
- Coordinate Requests for Information (RFI) processes across teams.
- Act as a Technical Coordinator for Clinical Trial Notifications via CTIS.
- Assist in defining and implementing new regulatory processes for evolving CTIS requirements.
- Identify and resolve any issues impacting submission timelines within CTIS.
Eligibility Criteria
Education & Experience:
- Bachelor’s Degree with 0-3 years of related experience OR
- Diploma with 4-7 years of related experience
Preferred Skills:
- Experience with Veeva Vault (Preferred)
- Familiarity with global regulatory processes and standards
- Ability to quickly learn new software, regulations, and processes
- Strong problem-solving, time management, and teamwork skills
Why Join Amgen?
- Work/Life Balance with time management support
- Opportunity to work on challenging projects in the pharmaceutical industry
- Comprehensive benefits including insurance
- A collaborative work environment with opportunities for professional growth
How to Apply?
Interested candidates can apply online for this Regulatory Affairs Job in Hyderabad at Amgen. Don’t miss this opportunity to be part of a company committed to innovation and patient care! Amgen Hiring Global Regulatory Affairs
Apply now and take the next step in your pharmaceutical regulatory affairs career!
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