Astellas Pharma Hiring Regulatory Affairs Specialist CMC in Bengaluru for B.Pharm, M.Pharm, MSc candidates with regulatory experience.
Introduction
Regulatory Affairs professionals play a critical role in ensuring that pharmaceutical products meet global regulatory requirements before reaching patients. These experts manage regulatory documentation, coordinate submissions to health authorities, and ensure compliance with international guidelines related to drug development and manufacturing.
Astellas Pharma has announced an excellent career opportunity for experienced professionals in Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC). The company is currently hiring a Regulatory Affairs Specialist – CMC for its Bengaluru location. This role is ideal for candidates with pharmaceutical regulatory experience who want to contribute to global regulatory strategies and support the development of innovative medicines. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Company Overview
Astellas Pharma is a global pharmaceutical company dedicated to improving the health of people around the world through innovative medicines. The organization operates in more than 70 countries, focusing on research, development, and commercialization of therapies that address serious medical needs.
The company has established Global Capability Centers (GCCs) to strengthen research support, regulatory operations, and innovation across its international network. Through these centers, Astellas collaborates with experts worldwide to enhance operational efficiency and accelerate the delivery of new therapies. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Job Location & Employment Type
| Job Detail | Information |
|---|---|
| Company | Astellas Pharma |
| Job Role | Regulatory Affairs Specialist – CMC |
| Department | Regulatory Affairs |
| Location | Bengaluru, Karnataka, India |
| Employment Type | Full-Time |
| Industry | Pharmaceutical / Regulatory Affairs |
| Experience Required | 3 – 6 Years |
| Application Mode | Online Application |
Department Overview
The Regulatory Affairs department is responsible for managing regulatory submissions and ensuring that pharmaceutical products comply with health authority requirements across different regions. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Within this department, the CMC Regulatory Affairs team focuses on the chemistry, manufacturing, and controls aspects of pharmaceutical products. The team ensures that manufacturing processes, quality standards, and product documentation meet global regulatory guidelines before and after product approval. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Key Roles & Responsibilities
Regulatory Strategy Development
- Develop regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical products.
- Provide regulatory guidance for product development projects and lifecycle management activities.
- Ensure that regulatory strategies align with global health authority requirements.
Regulatory Submissions
- Prepare and manage regulatory submission packages including:
- Investigational New Drug (IND) applications
- Clinical Trial Applications (CTA)
- New Drug Applications (NDA)
- Marketing Authorization Applications (MAA)
- Amendments and supplements
- Ensure submissions are prepared according to regulatory guidelines and internal procedures.
Documentation Management
- Compile and maintain CMC dossiers and regulatory documentation.
- Ensure proper version control and organization of regulatory files.
- Maintain accurate documentation for regulatory review and audit readiness.
Scientific Data Evaluation
- Review scientific and technical data related to product development and manufacturing processes.
- Assess compliance with regulatory requirements and identify potential regulatory risks.
- Ensure product data aligns with regulatory strategies and guidelines.
Cross-Functional Collaboration
- Work closely with departments such as research, manufacturing, quality assurance, and regulatory teams.
- Coordinate with internal stakeholders to collect necessary CMC information for submissions.
- Support communication with regulatory authorities when required.
Regulatory Compliance & Monitoring
- Monitor evolving regulatory guidelines and industry standards.
- Evaluate product or process changes to determine their regulatory impact.
- Provide guidance to project teams on regulatory compliance and documentation requirements.
Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Eligibility Criteria
Education
Candidates should possess one of the following qualifications:
- B.Sc / M.Sc in Life Sciences or related discipline
- B.Pharm / M.Pharm
- MS / PhD / PharmD in relevant scientific fields
Experience
- Minimum 6 years of experience in the pharmaceutical industry, including at least 3 years in Regulatory Affairs.
- Experience handling CMC regulatory submissions and documentation.
Skills Required
- Strong understanding of pharmaceutical development and manufacturing processes.
- Knowledge of ICH guidelines and global health authority regulations.
- Experience preparing regulatory submission documents and CMC dossiers.
- Strong project management and organizational skills.
- Ability to manage multiple projects simultaneously.
- Excellent written and verbal communication abilities.
- Strong documentation management and computer skills.
Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Preferred Qualifications
Candidates with the following additional qualifications may have an advantage:
- Advanced academic degree such as MS, PhD, or PharmD.
- Experience in pharmaceutical product development or regulatory strategy.
- Knowledge of regulatory processes for New Chemical Entities (NCEs) and New Biological Entities (NBEs).
- Experience working in global cross-functional teams.
- Understanding of regulatory requirements for combination products.
Salary & Benefits
Estimated salary range for this role:
₹18,00,000 – ₹32,00,000 per year
Additional benefits may include:
- Comprehensive health and medical insurance
- Global collaboration opportunities with international teams
- Professional training and career development programs
- Exposure to global pharmaceutical regulatory projects
- Inclusive and diverse workplace environment
Selection Process
The recruitment process may include the following stages:
- Application Screening
- HR Interview
- Technical Interview (Regulatory Affairs / CMC Expertise)
- Final Selection
Shortlisted candidates will be contacted by the Astellas recruitment team. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
How to Apply
Interested candidates can apply through Astellas Pharma’s official careers portal or verified company job listings. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Applicants should ensure that their resume highlights:
- Regulatory Affairs experience
- CMC regulatory documentation expertise
- Knowledge of global regulatory guidelines and submission processes
Important Dates
| Event | Date |
|---|---|
| Application Deadline | Not Specified |
Candidates are encouraged to apply early.
Why Apply for This Pharma Job?
Regulatory Affairs professionals play an essential role in the pharmaceutical industry by ensuring that medicines meet international safety, quality, and regulatory standards. This role provides opportunities to work on global regulatory submissions, collaborate with cross-functional teams, and contribute to bringing innovative therapies to patients worldwide.
Joining Astellas Pharma allows professionals to gain exposure to international regulatory processes and work in a dynamic environment focused on pharmaceutical innovation and scientific excellence. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares pharmaceutical and life sciences job updates for informational purposes only. We are not affiliated with Astellas Pharma or any organization mentioned in this post. Candidates should verify job details on the official company website before applying. IndiaPharmaJobs.in does not charge any fee for job information. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
Final Call-to-Action
Regulatory Affairs professionals with experience in CMC documentation and pharmaceutical regulatory strategy should consider applying for this opportunity at Astellas Pharma. If you meet the eligibility criteria and want to work on global pharmaceutical submissions, submit your application through the official career portal for the Regulatory Affairs Specialist – CMC position in Bengaluru. Astellas Pharma Hiring Regulatory Affairs Specialist CMC
