These 6 key drivers could improve submissions processes in pharma Regulatory Affairs

The pharma Regulatory Affairs submissions process has long been a bottleneck in getting new drugs to patients. Filing delays, inefficiencies, and lack of coordination among clinical, regulatory, safety, and medical writing functions slow down innovation and cost both time and money. But recent advances in automation, generative AI, and process redesign offer a real opportunity for change.

A recent report by McKinsey & Company suggests pharma companies that adopt what they term submission excellence transformations can reduce the time from database lock to filing by 50-65%, slashing timelines from many months to a matter of weeks.

McKinsey & Company identify these key drivers of change:

McKinsey identifies six “building blocks” that, when combined, can create a sustainable, high-quality submission process:

• Simplification of filing strategy Being very deliberate about defining the desired product label, and aligning clinical, safety, regulatory, and marketing teams early on to ensure that study design, data capture, and reporting all support that target label.
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• Zero-based redesign of the submission process Rather than incremental tweaks, this means rethinking processes from first principles (“last patient’s last visit to filing”), eliminating non-essential activities, employing lean methods, parallelising work, front-loading as many tasks as feasible.
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• Radical change of the operating model Creating cross-functional teams (clinical, regulatory, medical writing, biostatistics etc.) that are empowered and accountable; strengthening leadership commitment; decisive governance.
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• Modernisation of core technology (digitisation + automation) Updating or building regulatory information management systems (RIMS), embedding automation, moving from document-heavy to data-centric workflows. McKinsey reports ~80% of top global pharma firms are modernising their RIMS already.
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• Scaling automation for manual tasks Many manual tasks still remain unautomated – things like creating tables, listings, figures; formatting; responding to health authority queries (HAQs). Scaling automation here delivers large gains in time and error reduction.
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• Scaling generative AI for content generation Use of gen AI in medical writing, especially for clinical study reports, summaries, labelling, safety/efficacy documents; also to help anticipate questions/regulator queries, and improve internal review. McKinsey cites an example where gen AI reduced first-draft CSR writing from 180 to 80 hours, halving errors.
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What further value can the key drivers of change mean for the pharma Regulatory Affairs sector?

• Faster filings = more value: Shortening submission timelines even by one month for a high‐value asset
• Extended period of exclusivity: Faster filings help align filing dates better with patent life, maximising time when a product is under protection.
• Lower cost & resource burden: Automation, lean process, fewer manual hand-offs, fewer errors = less rework.
• Improved alignment & quality: Early strategy alignment (clinical/regulatory/marketing), better internal reviews, fewer surprises with regulators.
• Competitive edge: Companies that adopt these transformations are pulling ahead; for others, falling behind risks losing market share or approval delays.

What are the challenges of implementation?

While the benefits are compelling, there are significant obstacles to implementation:

• Change management / culture: Resistance to process change, silos, lack of cross-functional collaboration.
• Capability gaps: Not all organizations have staff with AI/automation experience; regulatory talent may lack experience with technology or data workflows.
• Technology integration: Legacy systems, multiple global regulatory jurisdictions, different standards; integrating new RIMS or authoring platforms is nontrivial.
• Quality & compliance risks: Oversight is critical; humans must remain in the loop, particularly for safety, labelling, and highly regulated content.
• Regulator acceptance: Some regulators may be more comfortable with traditional dossier submissions; interaction with health authorities may require educating them or negotiating new workflows.
• Scalability: Pilots are one thing; scaling up across multiple assets, regions, and submission types is harder.

So, what should pharma Regulatory Affairs organisations do to stay ahead?

Based on McKinsey’s horizons of transformation, here are steps for regulatory affairs (RA) leaders to consider:

• Start small, but with priority assets: Use a few high-value or urgent assets as pilot cases for submission excellence efforts.
• Invest in technology roadmap: Modern RIMS, workflow automation, gen AI tools; plan for data-centric, not document-centric workflows.
• Redesign processes & governance: Zero-based redesign; cross-functional team structures; clear accountability; faster decision-making.
• Upskill people: Training in AI, data tools, lean process methodologies; changing mindsets towards earlier alignment and parallel working.
• Collaborate with regulators: Engage proactively with authorities; explore early submission discussions; share expectations; pilot digital or real-time review methods.
• Measure & track metrics: Database lock to filing time; error rates; rework; cost per submission; resource allocation; ensure progress is visible.

AI and process redesign are not just optional nice-to-haves for pharma regulatory affairs, they’re becoming essential differentiators. Companies that embrace submission excellence, invest in automation and generative AI, redesign core workflows and operating models, and build strong organisational capabilities are likely to lead in speed, compliance, and ultimately in delivering therapies to patients faster. For those slow to act, the risk is losing competitive ground, losing exclusivity time, and lagging behind in innovation.

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Hayley Shayestehroo

Senior Consultant