Job Title: ROW Implementation Labeling Lead
Company: Astellas
Location: Bengaluru, India
Job Type: Full-time
Reports to: Regulatory Affairs/Labeling Leadership
Travel: Not specified
Responsible for the development, implementation, and change control of new and revised local labeling for assigned Astellas products and regions. Ensures compliance with Company Core Data Sheets (CCDS), regional health authority requirements, and internal procedures. Researches government labeling initiatives and ensures timely adoption. Requires interaction across functions and maintains positive relationships with global stakeholders and business partners.
1. Labeling Compliance & Implementation:
Ensure compliance of local labeling by evaluating all CCDS/CCSI changes and implementing them on prescribed timelines.
Collaborate with Regulatory Leads on submission and implementation strategy for labeling.
Advise cross-functional teams on labeling content consistency and best practices.
2. Documentation & Review:
Participate in cross-functional labeling review team meetings.
Organize, compile, and maintain all documentation.
Ensure compliance of manual and electronic label history files.
3. Systems & Processes:
Support systems, processes, and operations for labeling development and changes.
Ensure compliance with internal procedures.
Participate in labeling development for regional product launches and ensure adherence to company and regulatory specifications.
4. Language & Translation Management:
Manage English Master files.
Oversee translation of labeling text into local languages per country requirements.
5. Stakeholder Engagement:
Establish strong working relationships with global stakeholders, affiliates, and business partners.
Contribute to decision-making on challenging labeling issues; escalate critical issues to management as needed.
Bachelor’s degree.
At least 6 years of industry experience, including 3 years in Regulatory Affairs.
Direct pharmaceutical labeling development experience with change control proficiency.
Knowledge of health authority regulations and guidelines (e.g., ICH) for labeling development, implementation, and compliance.
Experience interacting with stakeholders across the labeling process from content development to commercial supply.
Strong organizational skills, attention to detail, and ability to manage multiple projects simultaneously.
Excellent written and verbal communication skills in English.
Bachelor’s degree in a scientific discipline; advanced degree preferred.
Scientific knowledge in chemistry, general biological/physical science, and ability to apply it to regulatory issues.
Astellas’ Global Capability Centres (GCCs) in India, Poland, and Mexico enhance operational efficiency, resilience, and innovation.
GCCs enable timely response to business demands and co-locate core capabilities across the value chain.
GCCs support the company’s strategic priorities, sustainable growth, and commitment to turning innovative science into value for patients.
Safety Sciences & Labeling
Astellas is an equal opportunity employer (EOE) including Disability/Protected Veterans.
Committed to equality of opportunity in all aspects of employment.
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