Work as Regulatory Affairs CMC Manager at Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Post : Regulatory Affairs CMC Manager (SPPM)

Job Description
• 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

Candidate Profile
• 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

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

Additional Information
Experience : 5+ years
Qualification : Doctorate degree or Master’s degree OR Bachelor’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th June 2025