Regulatory Affairs CMC- Specialist

Roles & Responsibilities
• Act as CMC regulatory lead or deputy for assigned projects and products, with guidance on complex issues
• Develop and execute CMC regulatory strategies aligned with global regulatory requirements
• Plan, prepare, review, and submit CMC sections for INDs, CTAs, NDAs, MAAs, amendments, and supplements
• Manage preparation, review, version control, and submission of technical CMC documents
• Assess CMC development data and manufacturing changes for potential regulatory impact
• Respond to Health Authority queries, action letters, and deficiency responses
• Ensure CMC dossier management, documentation accuracy, and compliance with internal SOPs
• Ensure timely compilation and submission of regulatory packages within defined schedules
• Monitor and facilitate resolution of CMC issues that may impact regulatory approvals
• Advise internal teams on Health Authority and ICH regulatory requirements
• Stay updated on regulatory changes and share regulatory intelligence and learnings internally
• Collaborate with cross-functional and global teams, including manufacturing, quality, and regulatory stakeholders

Qualification
• Bachelor’s degree in a scientific or related discipline
• Advanced degree (MS, PhD, or PharmD) preferred

Experience
• Minimum 6 years of pharmaceutical industry experience
• At least 3 years of experience in Regulatory Affairs (CMC focus preferred)
• Experience in pharmaceutical drug development and product lifecycle management
• Exposure to regulatory submissions for NCEs, NBEs, or combination products (preferred)

Skills
• Strong knowledge of CMC principles and pharmaceutical development
• In-depth understanding of Health Authority and ICH regulations and guidelines
• Excellent regulatory writing and document management skills
• Strong project management, prioritization, and multitasking abilities
• High attention to detail with strong analytical and problem-solving skills
• Effective written and verbal communication skills
• Ability to work independently and influence cross-functional teams
• High integrity and ability to maintain confidentiality
• Strong computer literacy and familiarity with regulatory systems

About the Company
Astellas is a global pharmaceutical company dedicated to turning innovative science into value for patients. Through its Global Capability Centers (GCCs) located in India, Poland, and Mexico, Astellas strengthens operational efficiency, resilience, and innovation across the value chain. The Bengaluru GCC plays a key role in supporting global regulatory, scientific, and operational excellence while fostering collaboration, integrity, and sustainable growth.