Amgen, a global biotechnology leader, is hiring for three key roles in Hyderabad, India. If you are looking for opportunities in Regulatory Data Management, Clinical Trial Submission Management, or Regulatory Writing, this could be your chance to join a world-class organization.
1. Associate, Regulatory Data Management
Job ID: R-208730
Location: Hyderabad (On-Site)
Career Category: Operations
Job Description:
As an Associate in Regulatory Data Management, you will ensure compliance and smooth data flow across regulatory systems.
Key Responsibilities:
- Maintain Regulatory Information Management (RIM) systems.
- Archive clinical trial submissions and health authority correspondence.
- Act as a liaison between regulatory teams and partners.
- Support data streamlining projects and generate reports.
- Assist in managing US CPP & EU CMP certifications.
Requirements:
- Master’s degree + experience OR
- Bachelor’s degree + 2 years experience OR
- Associate’s degree + 4 years experience OR
- High school diploma + 5+ years experience
- Familiarity with FDA, EMA, MHRA regulations.
- Preferred: Experience with Veeva Vault & IDMP standards.
2. Associate – Clinical Trial Submission Management
Job ID: R-206611
Location: Hyderabad (On-Site)
Career Category: Safety
Job Description:
Ensure EU Clinical Trial Applications (CTIS) compliance under EU CTR regulations.
Key Responsibilities:
- Prepare Submission Content Plans for regulatory filings.
- Perform Quality Control (QC) before CTIS upload.
- Manage Requests for Information (RFI) processes.
- Coordinate Clinical Trial Notifications in CTIS.
Requirements:
- Bachelor’s degree + 0-3 years experience OR
- Diploma + 4-7 years experience
- Preferred: Experience with Veeva Vault, regulatory processes.
3. Associate, Regulatory Writing
Job ID: R-210834
Location: Hyderabad (On-Site)
Career Category: Regulatory
Job Description:
Ensure high-quality regulatory documents for submissions.
Key Responsibilities:
- Perform document QC (formatting, consistency checks).
- Coordinate cross-functional document reviews.
- Manage timelines & submission readiness.
- Work on Clinical Study Reports, Protocols, ICFs.
Requirements:
- Bachelor’s degree in Science.
- 1-2 years in regulatory/medical writing.
- Strong MS Office & document management skills.
About Amgen
Amgen is a global biotech pioneer specializing in innovative medicines for serious illnesses. With a strong presence in Hyderabad, the company offers:
- Competitive salaries & benefits
- Career growth opportunities
- Inclusive & collaborative culture
How to Apply?
Application Link For Associate, Regulatory Data Management
Application Link For Associate – Clinical Trial Submission Management
Application Link For Associate, Regulatory Writing
