GRA CMC Lead

Role Summary

GRA CMC Lead within the GRA CMC & GRA Device Organization, driving global regulatory strategies for pharmaceutical and vaccine products. Collaborates with cross-functional teams to navigate regulatory landscapes, optimizes development and manufacturing processes, and influences drug approvals through strategic negotiations with health authorities worldwide. Serves as the primary liaison with regulatory authorities (FDA, EMA) and guides lifecycle regulatory planning across R&D, Manufacturing, and Quality.

• Shape the Future of Medicine:
  Guide products from early development to market by creating smart regulatory strategies and working directly with health authorities like FDA and EMA.
• Be a Problem Solver:
  Identify potential challenges early, develop practical solutions, and help teams navigate complex regulatory requirements.
• Build Strong Relationships:
  Collaborate with diverse teams across R&D, Manufacturing, and Quality to drive success.
• Make Smart Decisions:
  Assess risks and opportunities for pharmaceutical products to balance innovation with compliance.
• Drive Quality:
  Review regulatory submissions and provide strategic guidance to ensure high submission standards.
• Stay Ahead of Changes:
  Monitor evolving regulations and industry trends to anticipate and adapt to new requirements.
• Lead with Impact:
  Influence product development strategies and grow expertise within a supportive, inclusive environment.

• Experience:
  
  Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Education:
  
  Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
• Regulatory Expertise:
  Experience preparing regulatory documentation and familiarity with standard submission processes.
• Technical Knowledge:
  Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
• Collaboration
  
  Skills:
  
  Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
• Communication:
  Strong written and verbal communication skills, with fluency in English.
• Adaptability:
  Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

• Regulatory strategy development
• Cross-functional collaboration
• Regulatory submissions and health authority interactions
• Risk assessment and problem solving
• Effective written and verbal communication

• Bachelor's degree in Chemistry, Biology, Pharmacy, or related field

• Hybrid work environment with approximately 60% on-site work