Job Title: Partner, RA Regulatory Product Information Management
Job ID: #1794
Location: Bengaluru, India
1. Purpose and Scope
The Partner, RA Regulatory Product Information Management is responsible for organizing and managing regulatory operations activities across assigned projects and products. This includes planning and tracking regulatory applications, maintaining structured regulatory data, and ensuring compliance with submission standards. The role requires close collaboration with global Regulatory Affairs personnel to resolve operational complexities and drive process improvements. Additionally, the position involves strategic interactions with regional health authorities and cross-functional teams such as Pharmacovigilance, Data Science, Supply Chain, Marketing Operations, Manufacturing, and Medical & Development. The Partner also contributes to significant project teams and task forces.
2. Responsibilities and Accountabilities
A. Regulatory Data & Information Management
Ensure accuracy and completeness of global regulatory product data, metadata, and other regulatory information.
Review quality documents and reference materials to ensure compliance with regulatory data standards and industry best practices (Data Steward role).
Oversee daily operations of the Global Regulatory Information Management (RIM) system, including:
Data entry
Quality control
Metrics monitoring
B. Regulatory Processes & Compliance
Support and develop business processes required to capture and track regulatory events/information based on regional/local regulatory requirements.
Ensure adherence to submission standards and compliance guidelines across regulatory operations.
Contribute to the alignment of vocabulary management across RA systems in collaboration with Data Governance and Compliance.
C. Cross-Functional Reporting & Collaboration
Design and test reports sharing regulatory information with cross-functional stakeholders, including:
Pharmacovigilance
Medical Affairs
Development Operations
Finance
Senior Management
Support the preparation and transmission of data-centric submissions such as:
XEVMPD (Extended EudraVigilance Medicinal Product Dictionary)
IDMP (Identification of Medicinal Products)
D. Stakeholder Engagement
Collaborate with Regulatory Affairs stakeholders to integrate and share regulatory information with internal and external systems.
Work with regional health authorities to support regulatory operations and data submissions.
Participate in project teams and task forces with increasing strategic importance.
3. Required Qualifications
Bachelor’s degree (Science or Technology preferred).
Minimum 3 years of experience in the pharmaceutical industry, with exposure to regulatory operations.
Ability to work independently with minimal supervision.
Strong prioritization and multitasking skills across complex projects.
Effective communication and relationship-building skills to influence peers and stakeholders.
Excellent verbal and written communication in English.
High integrity and ability to handle confidential/regulatory information.
Ability to remain calm and focused under pressure.
4. Preferred Qualifications
Advanced degree (Master’s, PhD, etc.).
Minimum 6 years of experience in regulatory operations or related areas.
Experience supporting or managing regulatory IT systems.
Familiarity with:
Document management
Submission publishing
Registration management
Labeling systems
Change control systems
Basic understanding of:
Information taxonomies
Master data management
Structured data models
Data warehouses, data lakes, analytics platforms
Additional language proficiency (e.g., Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese).
5. Working Environment
Astellas offers a hybrid working model that supports work-life balance, allowing employees to work from both office and home. Hybrid flexibility is provided in alignment with Astellas’ Responsible Flexibility Guidelines. The role may involve collaboration with global teams and occasional business-related travel.
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