Astellas Pharma is hiring a Regulatory Affairs CMC Specialist at its Global Capability Center (GCC) in Bengaluru, India. This is an excellent opportunity for experienced Regulatory Affairs CMC professionals to work on global pharmaceutical submissions, lifecycle management, and advanced CMC regulatory strategies within a leading multinational innovator.
Astellas’ GCCs in India, Poland, and Mexico play a critical role in strengthening regulatory excellence, innovation, and operational efficiency across global drug development programs.
This role requires strong expertise in CMC regulatory submissions, cross-functional collaboration, and interpretation of ICH and global Health Authority regulations.
🧪 Key Responsibilities – Regulatory Affairs CMC Specialist
- Act as CMC Regulatory Lead or Deputy for complex pharmaceutical projects
- Develop and execute regulatory CMC strategies for assigned products
- Prepare and manage INDs, CTAs, NDAs, MAAs, amendments, and supplements
- Review CMC scientific data for regulatory compliance and submission readiness
- Respond to Health Authority questions and action letters
- Assess CMC changes for regulatory impact and product lifecycle management
- Ensure CMC dossier management, version control, and document integrity
- Maintain submissions in line with Astellas SOPs and global regulatory standards
- Advise internal stakeholders on ICH and Health Authority requirements
- Monitor evolving regulatory guidelines and share regulatory intelligence
🎓 Required Qualifications
- Bachelor’s degree in Science, Pharmacy, Chemistry, or related discipline
- Minimum 6 years of pharmaceutical industry experience
- At least 3 years of Regulatory Affairs (CMC) experience
- Strong knowledge of ICH guidelines and global regulatory frameworks
- Experience with drug development, manufacturing, or CMC documentation
- Excellent regulatory writing, communication, and project management skills
- High integrity and ability to manage confidential regulatory information
⭐ Preferred Qualifications
- Advanced degree: MS, PhD, or Pharm.D
- 5+ years of experience in CMC regulatory strategy or manufacturing/regulatory roles
- Experience with NCEs, NBEs, and product lifecycle maintenance
- Exposure to combination products (preferred)
- Ability to work in global, cross-functional teams
- Strong analytical thinking, decision-making, and problem-solving skills
- Fluent written and spoken English
💼 Benefits of Working at Astellas
- Global exposure to high-impact regulatory submissions
- Work within a world-class Global Capability Center
- Career growth in Regulatory Affairs CMC leadership roles
- Collaborative and inclusive work culture
- Competitive compensation and benefits package
- Opportunity to contribute to innovative medicines for patients worldwide
📍 Job Location
Bengaluru, Karnataka, India
(Hybrid / Partial On-site work required)
📨 How to Apply
