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Amgen
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Regulatory Affairs CMC Manager (SPPM)

Regulatory Affairs CMC Manager (SPPM)

Amgen

7 - 8 years

13 - 17 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

PMP Manager Quality Assurance Process planning Project management Analytical Pharma Process improvement Life sciences Document management Continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

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/ Doctorates 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:

Bachelor s degree or higher in Life Sciences, Engineering, or a related field
Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry
Working knowledge of Regulatory CMC processes and global submission requirements
Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs
Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms)
Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus

Collaboration & Communication Skills:

Strong project management and organizational skills with the ability to manage multiple priorities
Excellent written and verbal communication skills, with experience presenting to diverse audiences
Demonstrated ability to collaborate across global, cross-functional, or matrixed teams
Experience supporting onboarding, training, or continuous improvement initiatives
Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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Regulatory Affairs CMC Manager (SPPM)