Partner / Senior Manager – Regulatory Affairs (Regulatory Product Information Management)
Job ID: #1794
Location: Bengaluru, India
Position Type: Full-time
1. Purpose & Scope (Role Summary)
This role manages and organizes the regulatory operations aspects of projects and products. Key responsibilities include:
Planning, tracking, and maintaining structured regulatory data and applications submitted to health authorities.
Ensuring adherence to submission standards and regulatory data requirements.
Collaborating across the global Regulatory Affairs (RA) network to resolve procedural and operational complexities.
Leading process improvements for regulatory information flow and data accuracy.
Engaging strategically with multiple regional health authorities and cross-functional teams such as PV, Marketing Ops, Data Science, Supply Chain, Manufacturing, Medical & Development.
Serving on increasingly significant project teams/task forces.
2. Responsibilities & Accountabilities
A. Regulatory Data & Information Management
Ensure accuracy and completeness of global regulatory product data, metadata, and reference documents.
Act as Data Steward by verifying adherence to data standards and industry best practices.
Manage daily operations of the Global Regulatory Information Management (RIM) system, including:
Data entry
Quality control
Metrics tracking
B. Business Processes & System Integration
Support and design processes to capture/track regulatory events in compliance with local requirements.
Collaborate with RA stakeholders to share regulatory information with internal/external systems.
Identify opportunities for vocabulary alignment across RA systems with the Data Governance & Compliance team.
C. Reporting & Cross-Functional Support
Design, test, and deliver regulatory reports for cross-functional teams, including:
Pharmacovigilance
Medical Affairs
Development Operations
Finance
Senior/Top management
D. Data-Centric Regulatory Submissions
Support preparation and submission of:
XEVMPD (EVMPD)
IDMP
Ensure timely and compliant data transmission.
3. Required Qualifications
Education
Bachelor’s degree (Science or Technology preferred)
Experience
Minimum 3 years in the pharmaceutical industry with experience in Regulatory Operations
Demonstrated ability to work independently and within project teams
Strong prioritization and multitasking skills
Excellent verbal and written communication in English
Ability to work under pressure and maintain confidentiality
Skills
Strong interpersonal and collaborative abilities
Ability to influence peers and partners effectively
High integrity and strong organizational discipline
4. Preferred Qualifications
Master’s degree or PhD
6+ years of experience in Regulatory Operations or similar roles
Experience with IT systems, business operations support, and regulatory tools such as:
Document management systems
Submission publishing systems
Registration management or labeling systems
Change control platforms
Knowledge of:
Information taxonomies
Master Data Management (MDM)
Structured data concepts
Data lakes, data warehousing, analytics platforms
Proficiency in additional languages (e.g., Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese)
5. Working Environment
Hybrid work model offered under Astellas’ Responsible Flexibility Guidelines.
Combines office collaboration with remote work flexibility.
May involve cross-functional interactions across global teams.
6. Additional Note: Recruitment Integrity
Astellas warns against recruitment scams. Genuine communication will only come from:
Official Astellas email domains
Verified Astellas LinkedIn profiles
Report suspicious activity to LinkedIn Support.
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