Amgen, one of the world’s leading biotechnology companies, is hiring for the position of Associate – GSIM Regulatory Data Management at its Hyderabad location. This is a great opportunity for candidates with a background in Regulatory Affairs, Clinical Submissions, or Document Management to join a global biopharma leader.
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About the Company
Amgen is a pioneer in biotechnology with a strong commitment to discovering, developing, and delivering innovative human therapeutics. The company has a significant presence in India with its Global Capability Center in Hyderabad, supporting various functions including Regulatory Affairs, Clinical Development, and Operations.
Amgen offers a collaborative, high-performance work culture with excellent learning and career growth opportunities.
Job Details
- Position: Associate – GSIM Regulatory Data Management (GRAAS Operations)
- Job Requisition ID: R-242351
- Department: Global Regulatory Affairs Execution Team (GRAAS) – Global Submission & Information Management (GSIM)
- Location: Hyderabad, India
- Work Type: Full-time, On-site
- Career Category: Regulatory Affairs
Job Summary
As an Associate – GSIM Regulatory Data Management, you will play a key role in ensuring smooth and compliant flow of regulatory information between internal functions, local offices, external partners, and regulatory authorities.
You will support submission tracking, document management, data quality, and regulatory compliance activities.
Key Responsibilities
- Monitor regulatory data quality and support maintenance of planned submission and approval dates
- Update and maintain the Regulatory Submissions and Document Information Management System (RSDIMS)
- Compile and analyze regulatory metrics and reports
- Manage requests in the Regulatory Intake System
- Maintain regulatory document management and tracking systems
- Create and archive Clinical Trial Applications and Marketing Authorization submissions
- Manage on-site hard copy regulatory archives and off-site document storage
- Act as a point of contact between Regulatory Representatives, CMC, and publishing teams
- Handle Protocol Amendment New Investigator (PANI) submissions and Principal Investigator updates
- Manage 1572 forms for FDA submissions
- Provide support to the Regulatory Affairs (RDA) team and external vendors/CROs
- Ensure compliance with SOPs and regulatory authority requirements
Eligibility Criteria
Education & Experience (Basic)
- Bachelor’s degree OR
- Associate’s degree + 4 years of directly related experience OR
- High school diploma / GED + 6 years of directly related experience
Preferred Qualifications
- Experience in an operationally focused role within Regulatory Affairs
- Basic understanding of Global Clinical Trial Applications and Marketing Authorizations
- Familiarity with Veeva Vault system
- Prior experience in document management, submissions tracking, or regulatory operations
Required Skills
- Good written and verbal communication skills
- Strong attention to detail and critical thinking
- Ability to work independently and manage time effectively
- Excellent teamwork and collaboration skills
- Positive attitude with professionalism and diplomacy
- Proficiency in relevant software tools
How to Apply
Interested candidates can apply directly through Amgen’s official careers portal using Job Requisition ID: R-242351.
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Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Amgen Career page.
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Search for the position “Associate GSIM Regulatory Data Management” at Hyderabad on Amgen Careers website.
For more Regulatory Affairs jobs, biotech jobs, and pharma jobs in Hyderabad, visit Pharma Recruiter.
Why You Should Join Amgen
- Work with a global biotechnology leader at its Hyderabad Global Capability Center
- Gain exposure to international regulatory submissions and compliance
- Opportunity to work on high-impact regulatory operations supporting global drug development
- Collaborative work environment with strong focus on innovation and employee development
FAQs
What is the job ID for this Amgen Regulatory position?
The Job Requisition ID is R-242351.
Is this role completely on-site?
Yes, this is a full-time On-site position in Hyderabad.
What is the minimum qualification required?
Bachelor’s degree is preferred. Candidates with Associate’s degree + 4 years or High School + 6 years of relevant experience can also apply.
Is prior Regulatory Affairs experience mandatory?
Basic regulatory knowledge is expected. Experience in regulatory operations or document management is highly preferred.
Which system knowledge is desirable for this role?
Basic familiarity with Veeva Vault is considered an advantage.
This Amgen Hyderabad opening in Regulatory Data Management is ideal for candidates looking for a stable and growth-oriented career in Regulatory Affairs within the biotechnology sector. Apply now using Job ID R-242351.
