Global Regulatory Manager – Mumbai/Hyderabad
Job ID: REQ-10064285
Locations: Hyderabad / Mumbai, India
Division: Development
Business Unit: Universal Hierarchy Node
Employment Type: Full-time, Regular
Shift: No
Summary
The Global Regulatory Manager (GRM) is responsible for directing the development and submission of product registrations, progress reports, supplements, amendments, and periodic experience reports.
The role provides strategic product direction to project teams, negotiates with regulatory agencies, and serves as a regulatory liaison throughout the product lifecycle. The GRM ensures timely approval of new drugs, biologics/biotechnology products, and/or medical devices, as well as continued approved status of marketed products.
Key Responsibilities
Regulatory Strategy & Execution
Implement regulatory strategy and manage operational activities for assigned regions.
Contribute to global regulatory strategy, Regulatory Functional Plans (RFPs), and Seed Documents, identifying gaps or risks.
Partner with regions to align regulatory strategy with business objectives.
Determine requirements and set objectives for Health Authority (HA) interactions with DRA GPT representatives or GTAL.
Submission Management
Facilitate preparation and finalization of briefing books and summary documents.
Develop and implement plans for timely responses to HA requests.
Coordinate the planning and submission of dossiers in assigned regions.
Review global dossier summary documents and develop strategies to minimize review clock stops.
Review, approve, and submit Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and Risk Management Plans.
Health Authority Interaction
Serve as local HA liaison (e.g., FDA, EMA) depending on location.
Lead negotiations for regional approvals independently or with DRA GPT/GTAL guidance.
Ensure timely submission and approval of dossiers while mitigating potential risks.
Compliance & Risk Management
Report technical complaints, adverse events, or special case scenarios related to Novartis products within 24 hours of receipt.
Oversee the distribution of marketing samples where applicable.
Ensure alignment with regulatory, compliance, and internal guidelines.
Team & Project Leadership
Contribute to and often lead the development of departmental goals and objectives.
Influence cross-functional teams in regulatory decision-making and project planning.
Minimum Requirements / Skills
Functional breadth and experience in regulatory affairs.
Cross-cultural experience and ability to operate in matrix environments.
Strong operations management and execution skills.
Project management expertise.
Commitment to Diversity & Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities served.
Accessibility & Accommodation
Reasonable accommodations are available for individuals with disabilities during recruitment or to perform essential job functions. Contact: diversityandincl.india@novartis.com with the job requisition number and details of your request.
Why Novartis?
Novartis aims to reimagine medicine to improve and extend people’s lives. Its associates drive innovation and collaboration to achieve breakthroughs that change patients’ lives.
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