Regulatory Affairs CMC Manager (SPPM)

Let's do this. 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; and

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 :

• Support the new hire onboarding program
• Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness
• Drive consistency across Global CMC & Device Regulatory Affairs
• Develop and maintain training materials Global CMC & Device Regulatory Affairs
• Train staff on select departmental processes and procedures
• Ensure consistent use of processes and tools across department
• Continuous improvement of templates for presentations, timelines, trackers, and other tools
• Liaise with functions in GRAAS and Operations to ensure alignment
• Participate in cross-functional special project teams
• Potential to oversee or manage staff

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications :

Doctorate degree and 7 to 8 years of experience in manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry OR

Master's / Doctorate's degree and 8 to 12 years of experience in manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry OR

Bachelor's degree and 10 to 13 years of experience in manufacture, QA / QC, or regulatory CMC in the Pharmaceutical / Biotechnology industry

Preferred Qualifications :

Technical & Functional Expertise :

Collaboration & Communication

Skills :

Skills Required

Project Management, Communication Skills, Manufacturing