CMC Regulatory Affairs Process Specialist

2 days ago

Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 2,16,16,000 - ₹ 2,64,20,000

We are seeking a highly skilled Manager to join our team in the Global CMC & Device Regulatory Affairs department. The ideal candidate will be responsible for developing and maintaining consistency across practices and procedures related to CMC processes.

Key Responsibilities:
  • Support 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 for Global CMC & Device Regulatory Affairs
  • Train staff on select departmental processes and procedures
  • Ensure consistent use of processes and tools across departments
  • 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
Requirements:
  • Doctorate degree and 7-8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • OR Master's/ Doctorate's degree and 8-12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
  • OR Bachelor's degree and 10-13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
  • Technical 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
    • Certification or formal training in project management or process improvement methodologies is a plus
  • Collaboration & Communication:
    • 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

At Amgen, we value diversity and innovation. If you have a passion for making a difference in people's lives, join us as we continue to push the boundaries of what is possible.

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