Regulatory Affairs Specialist Job At Astellas
Astellas is hiring a Regulatory Affairs Specialist – CMC Small Molecules to support global CMC regulatory activities and submissions. Based in Bengaluru, this Regulatory Affairs Job role is ideal for regulatory professionals with experience in CMC, small molecules, and global health authority submissions who want to contribute to innovative science that delivers value to patients. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Specialist – CMC Small Molecules
- Location: Bengaluru, India
About the Company
Astellas is a global pharmaceutical company committed to turning innovative science into value for patients worldwide. Through its Global Capability Centers in India, Poland, and Mexico, Astellas enhances operational efficiency, innovation, and resilience while supporting sustainable growth and global regulatory excellence.
Educational Requirements
-
Bachelor’s degree (minimum) or a graduate degree (preferred) in Pharmacy
Key Responsibilities
- Contribute to the preparation, compilation, and submission of CMC regulatory dossiers as per global schedules.
- Support regulatory impact assessment and monitoring of CMC changes.
- Ensure accurate CMC documentation, version control, metadata, and dossier management.
- Support IND/CTA, original BLA/MAA, post-approval submissions, variations, and responses to health authority queries.
- Act as CMC RA Deputy to support Scientific Leads for development and commercial products.
- Identify, communicate, and escalate regulatory risks or issues proactively.
- Collect, interpret, archive, and share regulatory intelligence and requirements.
- Collaborate with Global Regulatory Affairs, QA, Product Development, and Manufacturing teams.
- Ensure full compliance with company SOPs, regulatory requirements, and training obligations.
- Execute assignments with high standards of efficiency, accuracy, innovation, and safety.
Skills Required
- Strong knowledge of CMC regulatory requirements and drug development lifecycle.
- Experience with small molecule regulatory submissions (preferred).
- Understanding of FDA, EMA, and ICH regulations and guidelines.
- Experience with regulatory or QA/GMP systems such as Veeva Vault, TrackWise Digital, or similar.
- Ability to critically review scientific data and technical documentation.
- Strong organizational, documentation, and data management skills.
- Proficiency in written and spoken English.
- Ability to manage multiple projects with overlapping timelines.
Why This Job Role?
This Regulatory Affairs Job role offers the opportunity to work within a global regulatory environment supporting innovative pharmaceutical products. At Astellas, you will collaborate across global teams, strengthen your CMC regulatory expertise, and play a key role in bringing high-quality medicines to patients worldwide. Graduates seeking B Pharma jobs or M Pharma jobs can apply now.
