Regulatory Specialist – Portfolio Acceleration and Analytics
Location: Hyderabad, Telangana, India
Job ID: R1598462
Department: Regulatory Affairs
Employment Type: Full-Time
ThePharmaDaily.com presents an opportunity for a Regulatory Specialist – Portfolio Acceleration and Analytics to support global regulatory operations and portfolio execution. This role is ideal for early-career regulatory professionals seeking hands-on exposure to international submissions, regulatory analytics, and cross-functional coordination within the pharmaceutical industry.
Position Summary
The Regulatory Specialist will provide coordination and operational support to cross-functional Global Regulatory Teams (GRTs) and Country Regulatory teams to ensure regulatory portfolio deliverables are executed according to timelines and in compliance with global processes and local regulatory requirements. The role supports regulatory acceleration strategies, submission readiness, compliance monitoring, and portfolio analytics.
Key Responsibilities
Global Regulatory Support
Maintain SharePoint systems and support GRT member transitions.
Coordinate execution of regulatory strategy plans.
Liaise cross-functionally to generate periodic milestone and portfolio status reports.
Conduct basic regulatory intelligence analyses as directed.
Global Regulatory Submissions Support
Support planning and on-time delivery of critical regulatory submissions, including registration samples and Module 1 documentation for ex-US and ex-EU markets.
Request regulatory certificates from Health Authorities such as FDA, EMA, and Swissmedic and manage related notification processes.
Coordinate shipping and administrative handling of regulatory documentation.
Ensure submission readiness through template setup and documentation review.
Health Authority Queries & Shortage Notifications
Schedule Regulatory Response Team (RRT) meetings and communicate timelines.
Prepare structured response templates for Health Authority queries.
Support publishing and submission of responses to regulatory authorities.
Divestitures, Product Deletions & Asset Integration
Upload documentation into Virtual Data Rooms (VDR) for product divestitures.
Coordinate product deletion strategies with Country Regulatory Managers.
Track deletion notifications with respective Health Authorities.
Support asset integration by uploading documents into internal systems and ensuring metadata accuracy.
Assist in remediation activities as directed.
Analytics & Compliance
Support preparation of Global Regulatory Strategy (GRS) analytics and monthly dashboards.
Track submissions, approvals, milestones, and compliance metrics.
Contribute to regulatory performance reporting and portfolio acceleration insights.
Experience Required
0–2 years of experience in the pharmaceutical or life sciences industry (entry-level regulatory professionals encouraged to apply).
Exposure to regulatory submissions, CMC documentation, or compliance tracking preferred.
Educational Qualification
Bachelor’s degree in Natural Sciences, Pharmacy, Life Sciences, Biotechnology, or a related healthcare field.
Core Competencies & Technical Skills
Working knowledge of international regulatory submissions and global Module 1 requirements.
Basic understanding of regulatory frameworks of FDA, EMA, and other global Health Authorities.
Exposure to CMC variation filings and Health Authority query management preferred.
Advanced proficiency in Veeva Vault with experience in regulatory workflows, reporting, and dashboard creation.
Ability to leverage AI and digital tools to enhance regulatory operational efficiency.
Strong analytical and organizational skills with attention to detail.
Ability to independently manage multiple assignments while supporting global teams.
Strong professional communication skills in English.
Proficiency in Microsoft Office Suite, Outlook, and standard business tools.
Good understanding of pharmaceutical and medical terminology.
Why This Role Is Strategic
This position plays a key role in accelerating regulatory portfolio execution through analytics-driven oversight, submission coordination, and global compliance management. It provides valuable exposure to international regulatory operations, cross-functional collaboration, and digital transformation within regulatory affairs.
Explore more Regulatory Affairs, CMC, Global Submissions, and Pharmaceutical Analytics roles on ThePharmaDaily.com – your trusted global life sciences career platform.
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