Partner – Regulatory Affairs, Regulatory Product Information Management
Location: Bengaluru, India
Job Type: Full-Time, Permanent
Department: Regulatory Affairs
About Astellas
Astellas Pharma is a global biopharmaceutical leader focused on improving the health of people worldwide through innovative therapies. Our mission is to transform patient outcomes by advancing science, leveraging technology, and fostering collaboration across research, regulatory, and operational functions.
The Regulatory Product Information Management team plays a critical role in ensuring the accuracy, compliance, and accessibility of regulatory data across global product portfolios, supporting regulatory submissions, lifecycle management, and cross-functional decision-making.
Role Overview
The Partner – RA Regulatory Product Information Management is responsible for organizing and managing regulatory operations, including planning, tracking, and maintaining regulatory submissions, structured product data, and associated metadata. This role requires strategic collaboration across global RA, Pharmacovigilance, Medical Affairs, Manufacturing, Supply Chain, and Development Operations.
The position involves both execution-focused and strategic responsibilities, supporting cross-functional teams and contributing to project teams, task forces, and regulatory initiatives at an increasing level of responsibility.
Key Responsibilities
Regulatory Data & Information Management
Ensure accuracy, completeness, and compliance of global regulatory product data and associated metadata.
Review reference materials and documents to align with regulatory data standards and industry best practices.
Perform or oversee daily operations of Regulatory Information Management (RIM) systems, including data entry, quality control, and metrics tracking.
Support the creation of business processes for capturing and tracking regulatory events in accordance with local requirements.
Collaborate with RA stakeholders to integrate regulatory information across internal and external systems.
Identify and implement opportunities for vocabulary management alignment across RA systems in collaboration with Data Governance teams.
Design, generate, and share regulatory reports and dashboards with cross-functional stakeholders, including senior management.
Support data-centric regulatory submissions, including XEVMPD and IDMP reporting.
Strategic & Cross-Functional Collaboration
Establish and maintain relationships with global RA teams to resolve operational challenges.
Collaborate with multiple departments including Pharmacovigilance, Medical Affairs, Supply Chain, Manufacturing, and Development Operations.
Contribute to process improvements and efficiency enhancements across regulatory operations.
Leadership & Execution
Serve as a key member of project teams or task forces, providing insights on regulatory product data management.
Support hybrid work environment with flexibility for both onsite and remote collaboration.
Maintain high integrity and confidentiality in handling sensitive regulatory data.
Qualifications & Experience
Required:
Bachelor’s degree in Science or Technology preferred.
Minimum 3 years of experience in the pharmaceutical industry, including regulatory operations exposure.
Strong communication skills (written and verbal English), with ability to influence and collaborate across teams.
Ability to prioritize, multi-task, and work independently in a dynamic environment.
Demonstrated problem-solving, analytical, and reporting skills.
Preferred:
Advanced degree (MSc, PhD) or equivalent.
6+ years of experience in regulatory operations or related roles.
Experience with IT systems, regulatory submission tools, document management, and registration management.
Knowledge of data taxonomies, master data management, data warehousing, and analytics platforms.
Multilingual proficiency (Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese) is an advantage.
Why Join Astellas
Work with a global, innovative biopharmaceutical leader driving patient-centric outcomes.
Engage in cross-functional, strategic projects with global impact.
Benefit from a hybrid working environment promoting work-life balance and productivity.
Be part of a diverse, inclusive organization committed to integrity, equality, and excellence in regulatory science.
Equal Opportunity Employer:
Astellas is committed to diversity, equity, and inclusion. Employment decisions are based on merit, qualifications, and organizational needs, without regard to race, gender, disability, veteran status, or other legally protected characteristics.
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