Join Amgen – Drive Regulatory Excellence in Global Biotech Innovation-Apply before 30th June 2025

Position: Manager – Regulatory Affairs CMC (SPPM)

Location: Hyderabad
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 30th June 2025

About Amgen

At Amgen, we combine the power of biotechnology and cutting-edge science to discover, develop, and deliver life-changing medicines. With over four decades of leadership in the biotech industry, we continue to push the boundaries of innovation to serve patients worldwide. Join us in our mission to fight the world’s toughest diseases and improve the quality of life for millions.

Role Overview

We are seeking a dynamic Regulatory Affairs CMC Manager (SPPM) to support and drive regulatory and operational excellence across our Global CMC & Device Regulatory Affairs function. The selected candidate will play a key role in strengthening process consistency, facilitating cross-functional communication, and enhancing onboarding and training practices.

Key Responsibilities

• Coordinate onboarding programs for new hires within the Global CMC & Device Regulatory Affairs team

• Develop and deliver training materials, processes, and SOPs for department-wide use

• Promote consistency and process excellence across regulatory functions

• Maintain and improve key departmental tools such as templates, trackers, and timelines

• Liaise with internal stakeholders across GRAAS and Regulatory Operations

• Contribute to special cross-functional project teams

• Potential to mentor or manage team members

Candidate Profile

Educational Qualification:

• Doctorate with 7–8 years OR

• Master’s with 8–12 years OR

• Bachelor’s with 10–13 years of experience in CMC, QA/QC, or manufacturing in the biopharma industry

Experience & Skills:

• Strong knowledge of Regulatory CMC and global submission processes

• Exposure to QA/QC, analytical development, or manufacturing functions

• Familiarity with regulatory tools such as Veeva Vault RIM or e-submission systems

• Experience creating and managing SOPs, training content, or onboarding programs

• Project management certification (e.g., PMP, Lean, Six Sigma) is a plus

Soft Skills:

• Excellent organizational, communication, and presentation abilities

• Proven track record of working across global, cross-functional teams

• Strong prioritization and multitasking capabilities in a deadline-driven environment

Why Join Amgen?

• Be part of a global leader in biotech innovation

• Work in a collaborative and forward-thinking environment

• Drive meaningful impact in shaping regulatory processes and patient outcomes

• Career growth opportunities in a purpose-driven organization

How to Apply

Submit your resume via the Amgen career portal or apply through internal referral channels. Ensure your application reaches us before 30th June 2025.