Senior Associate – Regulatory Project and Resource Management
📍 Location: Bengaluru, India
🏢 Category: Regulatory
🆔 Job ID: 429020
📅 Posted Date: October 14, 2025
Basic Qualifications & Responsibilities
Experience: 7–10 years in regulatory affairs.
Core Responsibilities:
Independently apply judgment and adhere to GSK and IRM plan quality standards, industry and regulatory standards, and drug development processes to deliver high-quality Regulatory Development Plans (RDPs).
Maintain integrated RDPs to operationalize the Global Regulatory Strategy (GRL), ensuring regulatory deliverables, timelines, and resource needs are captured for each development phase.
Provide regulatory functional line planning support at the project level, supporting multiple projects under one asset where applicable, from Commit to Candidate (C2C) through post-approval R&D activities.
Manage work packages within RDPs (add/delete/move) to reflect accurate development strategies, ensuring alignment with other plan types.
Review and manipulate predecessor/successor logic within RDPs, create alternative planning scenarios, and communicate drivers of regulatory deliverable dates to project teams and PMs.
Conduct scenario planning to support development team and portfolio decision-making.
Collaborate with other functional plan owners/project managers (Medical, Safety, Clinical) to ensure awareness of regulatory deliverables and alignment across all plan types.
Support R&D Governance Reviews (e.g., Development Review Board, Portfolio Investment Board, Dynamic Portfolio Review) by facilitating review of resource forecasts (EPE, IPE, FTE).
Build schedules to drive regulatory resource forecast estimates, including costs (EPE) and resources (FTE/IPE).
Partner with key stakeholders, including PMMT members and functional project managers, to ensure alignment of plan schedules with intended strategies.
Preferred Qualifications & Skills
Broad understanding of pharmaceutical industry, drug development, and R&D processes.
Project management experience, ideally in pharmaceutical or regulatory environments.
Knowledge of regulatory affairs responsibilities from pre-IND through post-approval.
Experience with project management tools (e.g., Planisware) and resource management/reporting systems (e.g., Spotfire).
Strong ability to work independently and within a matrix organization to ensure timely delivery of objectives.
Strong project management, prioritization, and stakeholder management skills across multiple functional areas.
Excellent written and verbal communication skills; able to present information clearly.
Familiarity with resource management and algorithmically driven resource forecasts.
Ability to assess and interpret regulatory resource needs in collaboration with functional line PMs and SMEs.
Why GSK?
GSK unites science, technology, and talent to advance disease prevention and treatment.
Focus on positively impacting 2.5 billion people by decade-end.
Therapeutic areas: respiratory, immunology & inflammation, oncology, HIV, infectious diseases.
Culture: ambitious for patients, accountable for impact, doing the right thing.
Inclusion & Accessibility
GSK encourages candidates to request accommodations during the recruitment process.
Contact: IN.recruitment-adjustments@gsk.com
Employment Agency & Legal Notices
GSK does not accept unsolicited agency referrals without prior written authorization.
Beware of fraudulent job postings or emails requesting payment; GSK does not charge fees for recruitment.
Verify suspicious communications via askus@gsk.com.
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