Regulatory Affairs Specialist – CMC (Medium-Sized Molecules / Oligonucleotides)
Location: Bengaluru, India
Job Type: Full-Time / On-site Hybrid
Experience Required: Minimum 6 years in pharmaceutical industry; at least 3 years in Regulatory Affairs
About Astellas Global Capability Centers (GCCs)
Astellas’ Global Capability Centers (GCCs) are strategically located in India, Poland, and Mexico, providing access to world-class talent across multiple functions. GCCs consolidate core capabilities, enhance operational efficiency, and drive innovation to respond effectively to evolving business and regulatory demands.
Our Bengaluru GCC plays a critical role in supporting Astellas’ mission of turning innovative science into value for patients, enabling sustainable growth and timely delivery of high-quality healthcare solutions.
Role Overview
The Regulatory Affairs Specialist – CMC will lead regulatory strategy and submission preparation for medium-sized molecules and oligonucleotide projects. This role requires strong expertise in CMC (Chemistry, Manufacturing, and Controls) to evaluate data, compile regulatory dossiers, manage submissions, and ensure compliance with global and local Health Authority regulations.
You will act as a key regulatory liaison, providing guidance to internal teams, interpreting complex regulations, and maintaining alignment with Astellas’ global regulatory strategy.
Key Responsibilities
Regulatory Strategy & Submission Management
Serve as CMC regulatory lead or deputy for complex projects, providing advice on CMC-related issues.
Develop and execute regulatory strategy for assigned projects, including INDs/CTAs, NDAs/MAAs, amendments, supplements, and Health Authority responses.
Evaluate scientific data against regulatory requirements and ensure submissions align with strategy.
Maintain proper CMC dossier management, including version control, documentation, and submission tracking.
Monitor and facilitate resolution of CMC issues impacting regulatory approvals.
Cross-Functional Collaboration
Collaborate with internal functional teams, external partners, and occasionally senior management to ensure timely regulatory compliance.
Advise local teams on Health Authority requirements, ICH guidelines, and product lifecycle management.
Communicate effectively to influence project teams and maintain alignment with organizational goals.
Compliance & Knowledge Management
Stay updated with changes in Health Authority regulations and guidelines, sharing insights across teams.
Provide training and guidance to peers on regulatory processes and CMC documentation standards.
Ensure all activities adhere to Astellas’ SOPs, regulatory standards, and global compliance requirements.
Qualifications
Required:
Bachelor’s degree in a scientific or related discipline.
Minimum 6 years of pharmaceutical industry experience, including 3 years in Regulatory Affairs (RA).
Solid scientific knowledge in chemistry, biological sciences, or related disciplines.
Experience in pharmaceutical drug development and CMC regulatory submissions.
Strong organizational skills with the ability to manage multiple projects and deadlines.
Proficiency in drafting regulatory documents with attention to compliance, clarity, and scientific accuracy.
Effective written and oral communication skills in English; ability to collaborate across cross-functional teams.
Preferred:
Advanced degree (MS, Ph.D., Pharm.D.) with 5+ years of experience in regulatory affairs and product development.
Knowledge of Health Authority regulations and regulatory processes for NCEs, NBEs, and lifecycle management.
Experience in combination products is an advantage.
Strong interpersonal and collaborative skills with the ability to work proactively in a fast-paced, dynamic environment.
Detail-oriented, quality-conscious, and able to manage complex projects independently.
Why Join Astellas
Work with a global biopharmaceutical leader and contribute to innovative healthcare solutions.
Exposure to international regulatory standards and multi-functional teams.
Opportunities for career growth in regulatory strategy, CMC leadership, and project management.
Be part of a company that values integrity, compliance, and patient-centric innovation.
Apply now on ThePharmaDaily.com to join Astellas as a Regulatory Affairs Specialist – CMC and help accelerate access to life-changing therapies globally.
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