The scoreboard, and what is not on it. The hard targets, how often each is actually
looked at, and the quiet signals that never reach a dashboard.
Global First-Pass Approval Rate
The percentage of major regulatory applications (e.g., NDAs, BLAs, MAAs) that receive approval on the first review cycle without significant delays or Refuse to File (RTF) decisions.
Target · Consistently >90% across all major markets In Q2, we filed 8 major applications globally; 7 received first-pass approval, one had minor queries resolved within the initial review period, resulting in an 87.5% first-pass approval rate. Your goal is to keep this above 90%.
Regulatory Compliance Audit Findings
The number and severity of findings from internal and external regulatory audits or inspections related to regulatory affairs processes and documentation.
Target · Zero critical or major findings annually Following the EMA inspection in Q3, our regulatory operations received zero critical observations and only two minor observations, both quickly addressed. Your aim is to maintain this clean record.
Time to Market (Regulatory Component)
The average time from the start of regulatory dossier assembly to final market authorisation, specifically focusing on the regulatory submission and review phases, benchmarked against industry averages.
Target · Top quartile performance against industry benchmarks (e.g., 10-15% faster than average) Our latest product launch achieved market authorisation 30 days ahead of the industry average for its therapeutic area, partly due to a streamlined regulatory submission strategy. You'll be driving these efficiencies.
Regulatory Budget Adherence
How well the global regulatory affairs budget (including personnel, systems, external consultants, and agency fees) is managed against approved forecasts.
Target · Within ±5% of approved annual budget The global regulatory budget for the year was £25M, and actual spend came in at £24.5M, a 2% variance. You're accountable for managing these significant resources effectively.
Board and Executive Confidence
The level of trust and reliance the Board and Executive Committee place in your regulatory advice, strategic guidance, and risk assessments.
- You're proactively consulted on all major strategic initiatives (M&A, new market entries, portfolio prioritisation). Your reports to the Board are concise, insightful, and lead to clear decisions. Executive leadership consistently seeks your input before making significant business commitments.
Regulatory Agency Relationship Strength
The quality and effectiveness of our relationships with key global health authorities, fostering open dialogue and proactive engagement.
- We have established formal and informal channels for constructive dialogue with agencies. We receive early feedback on regulatory changes. Agencies view us as a credible, transparent, and reliable partner, not just another applicant. You're known by name at the FDA, EMA, and other critical bodies.
Organisational Regulatory Acumen
The overall understanding and appreciation of regulatory requirements and their business impact across the wider organisation, driven by your leadership.
- Other functions (R&D, Commercial, Legal) actively seek regulatory input early in their processes. There's a clear understanding of 'why' we do certain things, not just 'what'. Regulatory considerations are embedded in our product development and commercialisation strategies from the outset.
Talent Development and Retention
Your ability to attract, develop, and retain top regulatory talent, building a robust succession pipeline for critical leadership roles.
- Key regulatory leadership positions have identified successors. We're seen as an employer of choice for regulatory professionals. Our internal development programmes are effective, and our team members are progressing through the organisation.
