Regulatory Affairs CMC Specialist Job in Bengaluru at Astellas Global to manage global CMC regulatory submissions and lifecycle activities.
About the Company
Astellas is a global pharmaceutical organization dedicated to turning innovative science into value for patients. With a strong focus on oncology, urology, immunology, and rare diseases, Astellas works at the intersection of cutting-edge research and patient-centered healthcare solutions.
Astellas operates Global Capability Centers (GCCs) designed to strengthen operational excellence, resilience, and innovation. These centers provide access to global talent and bring together critical capabilities that support the company’s worldwide operations. Regulatory Affairs CMC Specialist Job
Currently, Astellas has three strategically located GCCs:
- India
- Poland
- Mexico
These GCCs are fully integrated into Astellas’ global structure and play a key role in enabling sustainable growth, regulatory compliance, and efficient product development across markets. Employees working at GCCs are guided by Astellas’ shared values, ethical standards, and commitment to excellence. Regulatory Affairs CMC Specialist Job
Job Details
- Job Title: Regulatory Affairs CMC – Specialist
- Location: Bengaluru, India
- Work Mode: Hybrid (On-site presence required)
- Employment Type: Full-Time
- Industry: Pharmaceutical / Regulatory Affairs
- Functional Area: Regulatory Affairs – CMC
- Experience Level: Mid to Senior Level
- Category: Equal Opportunity Employer
Job Description
Astellas is seeking an experienced Regulatory Affairs CMC Specialist to join its Global Capability Center in Bengaluru. This role is critical to supporting global regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) across multiple development and commercial products. Regulatory Affairs CMC Specialist Job
The successful candidate will be responsible for developing and executing regulatory CMC strategies, preparing high-quality regulatory submissions, and ensuring compliance with global Health Authority and ICH requirements. This role requires a strong scientific background, deep understanding of pharmaceutical development, and the ability to interpret complex CMC data in a regulatory context.
The position offers an opportunity to work on global projects, interact with international teams, and contribute directly to the successful development and lifecycle management of pharmaceutical products. Regulatory Affairs CMC Specialist Job
Key Responsibilities
- Act as CMC regulatory lead or deputy for complex projects and products, seeking managerial guidance for highly complex issues
- Develop and implement regulatory CMC strategies aligned with global development plans
- Identify, collect, and evaluate CMC data required for regulatory submission packages
- Plan, prepare, review, and submit CMC sections of INDs, CTAs, NDAs, MAAs, amendments, and supplements
- Assess scientific and technical data against regulatory requirements and defined regulatory strategies
- Respond to Health Authority questions, deficiency letters, and action letters related to CMC topics
- Ensure proper CMC dossier management, including document version control and archival
- Ensure regulatory submissions meet defined timelines and comply with internal SOPs and Health Authority standards
- Monitor CMC changes and assess their potential regulatory impact on projects and marketed products
- Facilitate resolution of CMC-related issues that may affect regulatory filings or approvals
- Advise internal teams on regulatory requirements and interpretations of Health Authority and ICH guidelines
- Stay informed of evolving global regulatory regulations and expectations, sharing insights with stakeholders
- Collaborate regularly with internal functional teams and external partners, occasionally interacting with senior management
Regulatory Affairs CMC Specialist Job
Skills and Qualifications
Required Qualifications
- Bachelor’s degree in a scientific or related discipline
- Minimum of six years of total pharmaceutical industry experience
- At least three years of experience in Regulatory Affairs
- Strong scientific knowledge in chemistry and general biological or physical sciences
- Experience in at least one aspect of pharmaceutical drug development
- Working knowledge of global Health Authority and ICH regulations and guidelines
- Ability to interpret regulatory requirements and provide guidance to project teams
- Strong organizational skills with the ability to manage complex regulatory projects
- Proven ability to prioritize tasks and multitask with minimal supervision
- Excellent written and verbal communication skills suitable for regulatory documentation
- High level of integrity and ability to maintain confidentiality of proprietary information
- High level of computer literacy
Regulatory Affairs CMC Specialist Job
Preferred Qualifications
- Advanced academic degree such as MS, PhD, or PharmD
- Five or more years of relevant experience in manufacturing, product development, or regulatory affairs
- Experience with regulatory submissions for NCEs, NBEs, and lifecycle management activities
- Knowledge of global regulatory processes and expectations across multiple regions
- Experience in combination products is an added advantage
- Strong analytical thinking and independent decision-making skills
- Ability to work effectively in cross-functional and international team environments
- Detail-oriented, quality-focused, and customer-centric approach
- Strong problem-solving skills with the ability to identify and resolve issues efficiently
- Ability to work under strict timelines in a fast-paced environment
- Fluency in written and spoken English is mandatory
Regulatory Affairs CMC Specialist Job
Benefits and Perks
Astellas offers a competitive and comprehensive benefits package designed to support employee well-being, professional growth, and work-life balance. Regulatory Affairs CMC Specialist Job
Key benefits may include:
- Competitive compensation aligned with industry standards
- Health insurance coverage for employees and eligible dependents
- Retirement and long-term savings programs
- Paid time off and leave benefits
- Hybrid work model supporting flexibility
- Access to learning and development programs
- Opportunities for global collaboration and career progression
- Inclusive and diverse workplace culture
Benefits may vary based on role and location in accordance with local regulations. Regulatory Affairs CMC Specialist Job
Why You Should Join Astellas
Joining Astellas means becoming part of a purpose-driven organization focused on delivering meaningful value to patients worldwide. Employees are empowered to contribute to innovative science while developing their careers in a supportive and collaborative environment. Regulatory Affairs CMC Specialist Job
At Astellas, you will:
- Work on globally significant pharmaceutical projects
- Gain exposure to international regulatory strategies
- Collaborate with experienced professionals across regions
- Be part of a company committed to ethics, diversity, and inclusion
- Contribute directly to the development of high-quality, compliant medicines
Astellas is committed to equal opportunity in all aspects of employment and maintains a workplace free from discrimination and harassment.
Frequently Asked Questions (FAQs)
What is a Regulatory Affairs CMC Specialist?
A Regulatory Affairs CMC Specialist manages regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls for pharmaceutical products.
Is this role suitable for senior professionals?
Yes, this role is designed for experienced professionals with strong regulatory and CMC backgrounds.
Is the job fully remote?
No, this position is based in Bengaluru and requires some on-site work.
Does Astellas support global exposure?
Yes, the role involves collaboration with international teams and global regulatory authorities.
Is experience in combination products mandatory?
No, but it is considered an advantage.
How to Apply
Interested candidates should apply through the official Astellas careers portal or via verified Astellas recruiter communications. Applicants are advised to apply only through official company channels. Regulatory Affairs CMC Specialist Job
Astellas does not charge any fees during the recruitment process. Candidates should remain vigilant against recruitment scams and report any suspicious activity through LinkedIn Help or official company channels.
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
