Astellas Pharma has announced an exciting opportunity for professionals in Regulatory Affairs (CMC) to join its growing team in India. The company is looking for skilled candidates who can support regulatory strategy and manage Chemistry, Manufacturing and Controls (CMC) regulatory submissions for pharmaceutical products.
Astellas is a global pharmaceutical company operating in more than 70 countries, focused on developing innovative medicines for patients worldwide. Through its Global Capability Centers (GCCs), the company strengthens innovation, operational efficiency, and access to global talent.
This role offers an excellent opportunity for regulatory professionals to work on global submissions, collaborate with cross-functional teams, and contribute to bringing innovative therapies to patients.
Author: Pharmabharat Editorial Team
Job Overview
Company: Astellas Pharma
Position: Regulatory Affairs Specialist โ CMC
Location: Bengaluru, Karnataka, India
Department: Regulatory Affairs
Industry: Pharmaceutical Manufacturing
The selected candidate will be responsible for developing CMC regulatory strategies, preparing regulatory submission packages, and ensuring compliance with health authority requirements and international regulatory guidelines.
Roles and Responsibilities
The Regulatory Affairs Specialist will handle multiple regulatory activities related to pharmaceutical product development and submissions.
Key responsibilities include:
โข Develop regulatory CMC strategies for assigned projects and products.
โข Identify, collect, and organize CMC data required for regulatory submission packages.
โข Prepare and manage regulatory submissions such as INDs, CTAs, NDAs, MAAs, amendments, and supplements.
โข Review scientific data and assess compliance with regulatory strategies and health authority requirements.
โข Manage and maintain CMC dossier documentation and version control.
โข Ensure timely compilation and submission of regulatory documents according to regulatory standards and internal SOPs.
โข Evaluate product or process changes and assess potential regulatory impact.
โข Monitor and resolve CMC issues that may affect regulatory approvals.
โข Interact with internal functional teams and external regulatory bodies when necessary.
โข Provide regulatory guidance to project teams and ensure compliance with ICH and global health authority guidelines.
โข Stay updated with evolving regulatory requirements and share knowledge with the team.
Required Qualifications
Candidates applying for this role should meet the following requirements:
โข Bachelorโs degree in a scientific or related discipline.
โข Minimum 6 years of pharmaceutical industry experience, including 3 years in Regulatory Affairs.
โข Strong knowledge of chemistry, biological sciences, and pharmaceutical development.
โข Experience in preparing regulatory documentation and submission packages.
โข Understanding of Health Authority and ICH regulations and guidelines.
โข Strong project management and organizational skills.
โข Ability to prioritize tasks and manage multiple projects simultaneously.
โข Excellent written and verbal communication skills.
โข High integrity and ability to maintain confidential information.
โข Strong computer and documentation management skills.
Preferred Qualifications
Candidates with the following qualifications will have an advantage:
โข Advanced degree such as MS, PhD, or PharmD.
โข Additional experience in pharmaceutical product development or regulatory strategy.
โข Knowledge of regulatory processes for NCEs, NBEs, and lifecycle management.
โข Experience working in cross-functional and global teams.
โข Experience in combination products is considered a plus.
โข Strong analytical thinking and problem-solving skills.
Salary and Benefits
Astellas Pharma offers competitive compensation and benefits aligned with global pharmaceutical industry standards.
Estimated salary range for this role in India:
โข โน18,00,000 โ โน32,00,000 per year
Additional benefits may include:
โข Health and medical insurance
โข Global exposure and international collaboration
โข Professional development and training programs
โข Inclusive and diverse work culture
โข Opportunities to work on innovative pharmaceutical projects
How to Apply
Interested candidates can apply through the official Astellas Pharma careers portal or through the companyโs verified LinkedIn job listing.
Before applying, ensure that your resume highlights regulatory affairs experience, CMC documentation, and pharmaceutical regulatory knowledge.
Applicants should also be cautious of recruitment scams. Genuine communication from Astellas will only come from official company emails or verified company profiles.
