Regulatory Affairs CMC Manager (SPPM)

Let's change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by :

• Driving continuous improvement of processes and tools.
• Ensuring awareness of processes across the organization.
• Shaping the training strategy across the organization.

The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes.

Job Responsibilities of the SPPM Manager include :

What we expect of you :

Basic Qualifications :

Preferred Qualifications :

Technical & Functional Expertise :

Collaboration & Communication Skills :

Skills Required

Project Management, Veeva, Quality Assurance, Manufacturing, Vault