Regulatory Affairs Job at Astellas Pharma | Pharmacy Graduates Apply Now
Astellas Pharma is hiring a Specialist, CMC Regulatory Affairs for its Bangalore-based Global Capability Center. This Regulatory Affairs Job is designed for professionals with 3+ years of experience (or 1+ year with a graduate degree) in Regulatory CMC or biological research. The successful candidate will lead CMC submissions, manage regulatory impact assessments for small molecules and biologics, and ensure compliance across the drug product lifecycle—from IND/CTA to BLA/MAA and post-approval variations.
- Job Post: Regulatory Affairs Specialist
- Location: Bengaluru, IND
About The Company
Astellas Pharma Inc. operates in over 70 countries, turning innovative science into medical solutions for unmet needs. The Bangalore Global Capability Center (GCC) is one of three strategic sites (alongside Poland and Mexico) designed to centralize core capabilities, enhance operational resilience, and access top-tier global talent. Astellas emphasizes Responsible Flexibility, providing a hybrid work environment that balances home-based focus with office-based collaboration. Individuals pursuing a Regulatory Affairs Job will appreciate this company’s values and global impact.
Purpose and Scope
The Specialist, CMC Regulatory Affairs (RA), is responsible for supporting CMC regulatory activities for our company’s products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities, including supporting biologics programs, could be in the development or the marketed product phase of a drug product lifecycle. If your goal is building a career through a Regulatory Affairs Job, the scope here offers significant growth potential.
Responsibilities and Accountabilities
- Contribute to the preparation, compilation, and transmittal of CMC submissions according to the defined schedules and meet boththe Health Authority and Astellas established SOPs/guidance.
- Contribute to the regulatory impact assessment of proposed CMC changes and monitor the progress of the CMC changes with regulatory impact. Successful candidates for this Regulatory Affairs Job should demonstrate attention to detail in all compliance matters.
- Ensure proper CMC document, including version control and metadata, and dossier management.
- Support the CMC RA colleagues on assigned products and be accountable for the delivery of all assigned regulatory activities, including IND/CTA, original BLA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions per established business processes and systems.
- Identify, communicate, and escalate potential issues tothe CMC RA Scientific Lead.
- Act as CMC RA Deputy to support CMC RA Scientific Lead for both development programs and commercial products for regulator filing.
- Contribute to collecting, interpreting, archiving, and knowledge sharing of regulatory requirements for both BLA/MAA and post-approval submissions.
- Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our company’s human medicinal products worldwide.
- Conduct all activities with an unwavering focus on compliance, including staying current on all training.
- Carry out all assignments to the standards of efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements. Embarking on a Regulatory Affairs Job means continually learning and adapting to updated requirements.
- Additional activities may be assigned by the supervisor.
Quantitative Dimensions
- The position will interact with individuals outside of CMC Regulatory Affairs, such as Global Regulatory Affairs, Quality Assurance, Product Development, and Manufacturing. Collaboration is key within this Regulatory Affairs Job role.
- Position will provide support to multiple projects, some with overlapping timelines.
- Position should be able to apply scientific knowledge to assigned projects, and use working knowledge of relevant regulations and guidelines to assist in the success of projects and programs.
Required Qualifications
- Bachelor’s (minimum) or graduate degree (preferred) in engineering, or a related field. Fields of study include Pharmacy or other similar scientific disciplines, which are often essential for advancement in Regulatory Affairs Job opportunities.
- At least three (3) years of relevant experience in regulatory CMC, or biological or vaccine research, manufacturing, testing, or related fields for candidates with a bachelor’s degree or 1 year with a graduate degree.
- The ideal candidate must have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
- The ideal candidate must have strong organizational skills with the ability to combine information from different systems.
- The candidate must be proficient in English; additional language skills are a plus.
Preferred Qualifications
- Experience in small molecules is preferred.
- Experience in operating CMC regulatory and/or QA/GMP related database, such as Veeva Vault, TrackWise Digital, etc. Candidates with previous Regulatory Affairs Job background in these tools will have an advantage.
- Knowledge of FDA/EMA, ICH regulations and guidelines (and beyond), and the ability to provide interpretations of that information to others.
