Regulatory Affairs CMC Manager (SPPM)

Requirements

• Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• 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

Benefits

• Competitive and comprehensive Total Rewards Plans
• Collaborative culture
• Support for professional and personal growth and well-being