Project Risk Mitigation Strategies in Regulatory Affairs Operations

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Palak Gupta

ABES Engineering College

Chipiyana Buzurg, Ghaziabad, Uttar Pradesh, 201009. India

Abstract— Regulatory Affairs (RA) functions have become pivotal strategic partners in biopharmaceutical value chains, yet they routinely grapple with volatile regulatory landscapes, compressed commercial-launch horizons, and ever-growing documentation complexity. Conventional project-management frameworks often fail to reflect RA-specific constraints such as immovable Health Authority (HA) milestone dates, stringent data-integrity requirements across heterogeneous source systems, and the reputational ramifications of non-compliance. To close this gap, the present study develops and empirically validates an integrated risk-mitigation framework tailored for RA operations.

First, an extensive scoping review of 138 peer-reviewed papers, guidance documents, and industry white papers published between 2015 and 2024 synthesizes five dominant RA risk domains—timeline, data-quality, compliance, resource, and stakeholder misalignment—along with 12 candidate mitigation levers. Building on this foundation, a cross-sectional survey of 64 global pharmaceutical and biotech companies (n = 219 individual respondents) measures the perceived severity, frequency, and controllability of each risk-lever pairing. Exploratory factor analysis (EFA) and multivariate regression identify timeline constraints and data-quality issues as the most consequential drivers, jointly accounting for 62 % of the observed variance in submission delays and 55 % in budget overruns.

To translate these insights into operational guidance, we construct a discrete-event simulation (DES) of a parallel European Medicines Agency (EMA) centralized procedure and U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) dossier workflow. The simulation, parameterized with real-world cycle-time distributions, resource calendars, and HA query patterns from 2019-2024, evaluates four cumulative mitigation scenarios: baseline (manual processes), digital tracking, predictive resource leveling, and agile cross-functional “risk sprints.” Results demonstrate that layering all three mitigations cuts missed-deadline probability by 42 %, reduces cost overrun by 18 %, and lowers major HA query counts by 25 %. Sensitivity analyses reveal that digital dashboards deliver the fastest marginal benefit, whereas agile risk sprints drive the most sustained compliance-quality gains by uncovering cross-functional dependencies earlier in the lifecycle.

Managerial implications include (i) prioritizing investments in end-to-end submission visibility platforms, (ii) institutionalizing data-quality gates governed by automated integrity checks, and (iii) embedding short-cycle, cross-functional reviews that mirror agile software practices. By integrating survey analytics, statistical modeling, and simulation, this study offers a replicable playbook for RA leaders seeking to future-proof operations against escalating regulatory demands. Future work should examine biological-product post-approval variations and assess the interoperability of AI-driven risk-early-warning systems with evolving HA electronic submission portals such as FDA-NextGen.

Keywords

regulatory affairs, risk mitigation, submission lifecycle, compliance quality, discrete-event simulation

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Abhijeet Bhardwaj, Jay Bhatt, Nagender Yadav, Om Goel, Dr. S P Singh, Aman Shrivastav. Integrating SAP BPC with BI Solutions for Streamlined Corporate Financial Planning. Iconic Research And Engineering Journals, Volume 8, Issue 4, 2024, Pages 583-606.
Pradeep Jeyachandran, Narrain Prithvi Dharuman, Suraj Dharmapuram, Dr. Sanjouli Kaushik, Prof. (Dr.) Sangeet Vashishtha, Raghav Agarwal. Developing Bias Assessment Frameworks for Fairness in Machine Learning Models. Iconic Research And Engineering Journals, Volume 8, Issue 4, 2024, Pages 607-640.
Bhatt, Jay, Narrain Prithvi Dharuman, Suraj Dharmapuram, Sanjouli Kaushik, Sangeet Vashishtha, and Raghav Agarwal. (2024). Enhancing Laboratory Efficiency: Implementing Custom Image Analysis Tools for Streamlined Pathology Workflows. Integrated Journal for Research in Arts and Humanities, 4(6), 95–121. https://doi.org/10.55544/ijrah.4.6.11
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