Job ID: R-224555
Location: Hyderabad, India
Work Type: On-Site
Category: Regulatory
Amgen, a global leader in biotechnology, is inviting applications for the position of Sr. Associate – Regulatory Affairs at its Hyderabad location. With over 40 years of scientific innovation, Amgen continues to deliver breakthrough therapies and remains committed to improving patients’ lives worldwide.
About the Role
The position is part of Regulatory Affairs, Chemistry, Manufacturing, and Controls (RA CMC) under the ROOTS2 team (Regulatory Optimization of Tactical and Strategic Support). The team supports CMC and Device submission execution for Amgen’s products across multiple phases, modalities, and geographies.
The selected candidate will collaborate with global and site RA CMC teams, contribute to regulatory strategies, and manage CMC submissions throughout the product lifecycle.
Key Responsibilities
- Lead submissions for annual reports, facility registrations, renewals, and product renewals.
- Coordinate with authors, reviewers, and SMEs for CMC and Device submission documents.
- Prepare submission content plans for various applications, including IND/CTA, IDE/PSA/CIA, marketing applications, post-market variations, and annual reports.
- Manage country-specific document collection, legalization, and submission.
- Archive CMC submissions and related communications in document management systems.
- Maintain timelines at the direction of product leads and coordinate with regulatory operations.
- Provide status reports and train staff on select procedures and systems.
- Participate in cross-functional special projects.
Basic Qualifications
- Master’s degree OR
- Bachelor’s degree with 1–2 years of experience in manufacture, QA/ QC, or Regulatory CMC in the Pharmaceutical/ Biotech industry OR
- Associate’s degree with 6 years of relevant experience OR
- High school diploma/ GED with 8 years of relevant experience.
Preferred Qualifications
- Bachelor’s degree in Life Sciences.
- Experience in manufacturing, process development, QA/QC, or analytical development.
- Knowledge of IVD, Device, or Combination Product regulatory submissions.
- Strong project management, organizational, and communication skills.
- Familiarity with Veeva Vault platforms.
Why Join Amgen?
Amgen offers the opportunity to work on cutting-edge therapies, contribute to global regulatory strategies, and grow within a science-driven, patient-focused organization that is transforming healthcare.
👉 Apply Now: Amgen Careers – Job ID R-224555
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