Regulatory Affairs Specialist – CMC (Medium-Sized Molecules / Oligonucleotides)
Job ID: 25-PJT12487M
Location: Bengaluru, India
Employment Type: Full-Time
Work Mode: Hybrid (On-site presence required as per business needs)
Experience Required: 6–10 Years
Industry: Pharmaceuticals | Biotechnology | Life Sciences
Function: Regulatory Affairs – CMC
Job Overview
Astellas is seeking an experienced Regulatory Affairs Specialist – CMC to support medium-sized molecules and oligonucleotide programs. This role is a critical part of Astellas’ Global Capability Centers (GCCs) and will play a key role in developing and executing global CMC regulatory strategies across development and lifecycle stages.
The position is based in Bengaluru, India, and involves close collaboration with cross-functional global teams to ensure high-quality, compliant regulatory submissions aligned with international Health Authority and ICH requirements.
About Astellas – Global Capability Centers
Astellas’ Global Capability Centers (GCCs) in India, Poland, and Mexico are integral to the company’s global strategy. These centers enhance operational efficiency, resilience, and innovation by co-locating core capabilities across the value chain. The GCCs are embedded within Astellas’ culture and values, supporting sustainable growth and the mission to turn innovative science into value for patients worldwide.
Key Responsibilities
Serve as CMC Regulatory Lead or Deputy for complex projects and products, with guidance from management on advanced regulatory challenges
Develop and execute CMC regulatory strategies for assigned projects
Identify, collect, and evaluate CMC data required for global regulatory submissions
Prepare and manage INDs, CTAs, NDAs, MAAs, amendments, supplements, and responses to Health Authority queries
Assess CMC changes for potential regulatory impact and support change management activities
Ensure accurate CMC dossier management, including document version control and lifecycle maintenance
Ensure submissions are compiled and transmitted on time, meeting Health Authority, ICH, and internal SOP requirements
Interpret evolving global regulatory requirements and advise internal stakeholders accordingly
Monitor and resolve CMC-related issues with potential regulatory impact
Collaborate with internal and external stakeholders, including occasional interaction with senior management
Stay current with changes in global regulatory regulations and share regulatory intelligence across teams
Required Qualifications
Bachelor’s degree in a scientific or related discipline
Minimum 6 years of total pharmaceutical industry experience, including at least 3 years in Regulatory Affairs (CMC)
Strong scientific background in chemistry, biological sciences, or physical sciences
Hands-on experience in pharmaceutical drug development, manufacturing, or regulatory submissions
Working knowledge of Health Authority and ICH regulations and guidelines
Proven ability to manage complex projects, prioritize tasks, and work with minimal supervision
Excellent written and verbal communication skills with strong regulatory writing capability
High attention to detail, strong organizational skills, and project management capability
Proficiency in regulatory documentation systems and high computer literacy
Demonstrated integrity and ability to manage confidential and proprietary information
Preferred Qualifications
Advanced degree (MS, PhD, or PharmD) with 5+ years of relevant experience in product development, manufacturing, or regulatory affairs
Experience with NCEs, NBEs, and product lifecycle management
Knowledge of regulatory processes for medium-sized molecules, oligonucleotides, and combination products
Experience working in cross-functional, global, and multicultural environments
Strong analytical, decision-making, and problem-solving skills
Ability to work effectively in a fast-paced, deadline-driven environment
Fluency in written and spoken English
Location
Bengaluru, India
Important Notice
Astellas does not charge fees for recruitment. Official communication will only originate from a verified Astellas email address or an authentic Astellas LinkedIn profile. Candidates are advised to report any suspicious activity to LinkedIn Suppor
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