Partner, Regulatory Affairs – Regulatory Product Information Management
Job ID: 1794
Location: Bengaluru, India
Category: Regulatory Affairs
Role Overview
This role is responsible for leading and managing regulatory product information and supporting global regulatory operations. The position ensures accurate regulatory data management, compliance with submission standards, and effective coordination across regional and global stakeholders. It exists to maintain the integrity, quality, and consistency of regulatory product information used across the organization and regulatory agencies.
Key Responsibilities
Manage and organize regulatory operations activities for assigned products and projects, including planning, tracking, and maintenance of submissions and structured regulatory data.
Ensure compliance with global submission standards and regulatory requirements through continuous oversight and process alignment.
Build and maintain strong working relationships with Global Regulatory Affairs teams to address procedural, operational, and data-related challenges.
Contribute to strategic interactions with regional health authorities and collaborate with cross-functional teams, including Pharmacovigilance, Supply Chain, Manufacturing, Data Science, Marketing Operations, and Medical & Development.
Participate in and support major project teams and task forces within Regulatory Affairs.
Regulatory Information Management Responsibilities
Ensure accuracy, completeness, and compliance of global regulatory product data and metadata by reviewing quality documents and other reference materials.
Perform or supervise daily operations of the Global Regulatory Information Management (RIM) system, including data entry, quality checks, and reporting metrics.
Support and develop business processes for capturing and tracking regulatory events in compliance with regional regulatory requirements.
Collaborate with Regulatory Affairs stakeholders to supply regulatory information to internal and external systems through integration workflows.
Identify opportunities to standardize and align vocabulary management across RA systems in partnership with Data Governance and Compliance teams.
Design and test reports for cross-functional stakeholders, including Medical Affairs, Pharmacovigilance, Development Operations, Finance, and senior leadership.
Support preparation and submission of data-centric regulatory requirements such as XEVMPD and IDMP.
Required Qualifications & Experience
Bachelor’s degree in Science or Technology (preferred).
Minimum 3 years of experience in the pharmaceutical industry, with direct experience in regulatory operations.
Proven ability to work independently and collaboratively across global teams.
Strong organizational and multitasking capabilities with the ability to manage multiple projects simultaneously.
Excellent written and verbal communication skills in English.
High level of integrity with the ability to manage confidential regulatory and product information.
Ability to remain composed and effective under pressure.
Preferred Qualifications
Advanced degree (Master’s, PhD, or equivalent).
Six or more years of experience in regulatory operations or a closely related discipline.
Experience supporting IT systems or providing business operational support.
Working knowledge of document management, submission publishing, labeling systems, registration management, and change control systems.
Understanding of data taxonomies, master data management, structured data models, and regulatory data concepts.
Familiarity with data warehouses, data lakes, and analytics platforms.
Proficiency in additional languages such as Dutch, Japanese, Spanish, Portuguese, French, Russian, or Chinese.
Working Environment
This role follows a hybrid working model, combining on-site collaboration with remote work flexibility. The organization emphasizes work-life balance and provides a professional, collaborative environment aligned with global operational standards.
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