Roles & Responsibilities:
• Lead and execute CMC regulatory strategies for post‑approval pharmaceutical products globally.
• Prepare, review, and coordinate CMC documentation for post‑approval changes and lifecycle activities.
• Assess scientific and technical data to evaluate regulatory impact and ensure risk-based, data-supported rationales.
• Manage multiple CMC projects, ensuring timely, high-quality dossier submissions.
• Collaborate with cross-functional teams (QA, QC, manufacturing, supply chain, packaging, device, analytics) and provide regulatory updates.
• Translate complex technical concepts into clear regulatory justifications and influence cross-functional decisions.
• Identify regulatory risks and opportunities and implement compliant solutions.
• Participate in continuous improvement initiatives and maintain SOPs and internal guidelines.
• Mentor junior colleagues and represent CMC regulatory function in project meetings.
• Utilize MS Office and regulatory IT systems for efficient documentation management.
Qualifications:
• Bachelor’s or Master’s degree in Pharmacy, Science, or related field (advanced degree preferred).
Experience:
• 5-10 years of global Regulatory CMC experience.
Skills:
• Strong communication, regulatory strategy, and CMC documentation skills.
• Cross-functional collaboration and stakeholder management.
• Knowledge of pharmaceutical manufacturing, analytical testing, and quality systems.
• Advanced MS Office and regulatory IT proficiency.
• Leadership, mentoring, and project management abilities.
About the Organization:
Genpact is a global technology and professional services company that leverages deep industry expertise, advanced data, and AI-driven solutions to help enterprises transform and stay ahead. With a culture built on integrity, inclusion, and innovation, Genpact empowers over 140,000 professionals worldwide to solve complex business challenges, drive change, and deliver lasting value for clients across industries.
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