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.
Submission Acceptance Rate
How often our initial submissions are accepted for review by health authorities, rather than getting an 'RTF' (Refuse to File) letter.
Target · Consistently >95% for all major submissions Last quarter, you led three major new product submissions. All three were accepted without an RTF, hitting 100%.
Regulatory Review Cycle Efficiency
The average number of 'Information Request' (IR) cycles or deficiency letters we get before a product is approved, and how quickly we respond.
Target · Reduce average IR cycles by 15% year-on-year; 90% of IRs responded to within 75% of agency deadline. For Product X, you managed to get approval with only one round of IRs, cutting the typical two-round process down, saving us 60 days.
Regulatory Pathway Optimisation
Identifying and successfully pursuing accelerated or more efficient regulatory pathways (e.g., De Novo vs PMA, or specific designation applications).
Target · Successfully identify and secure 1-2 optimised pathways for key products annually, leading to a 6-12 month faster time-to-market. You successfully argued for a De Novo pathway for our new diagnostic, avoiding a much longer PMA process, saving us a year in development.
Team Mentorship & Development
The growth and capability of your direct reports, measured by their ability to take on more complex tasks and lead smaller projects.
Target · Each direct report shows measurable progress on their development plan, with at least one junior specialist ready for a mid-level role annually. Your junior specialist, Sarah, successfully led her first annual report submission independently this quarter, thanks to your guidance.
Strategic Influence & Proactivity
How often you're brought into early-stage product discussions to shape strategy, rather than just being handed a finished product to regulate. Are you anticipating issues?
- You're consistently invited to early-stage R&D meetings
- product teams proactively seek your advice before committing to designs
- you're seen as a partner, not just a gatekeeper. You spot potential regulatory changes before they impact us and have a plan.
Health Authority Relationship Management
The quality of our interactions with regulators – are they constructive, clear, and do we maintain a good reputation?
- Feedback from internal legal or senior management confirms clear, professional interactions
- you successfully negotiate tricky points with agencies while maintaining a positive relationship
- no unexpected escalations or negative agency feedback.
Cross-Functional Collaboration & Clarity
How effectively you get different internal teams (R&D, Clinical, Marketing) on the same page regarding regulatory requirements and timelines.
- Project teams consistently understand regulatory requirements
- fewer last-minute scrambles for documents
- positive feedback from R&D or Marketing about your ability to translate complex rules into actionable steps. You're the go-to person for regulatory questions.
Problem Solving & Judgment
Your ability to navigate ambiguous regulatory situations, make sound judgments, and propose pragmatic solutions when the rules aren't clear.
- You present well-reasoned options for complex regulatory challenges, clearly outlining risks and benefits
- your solutions are often adopted by leadership
- you rarely need to escalate routine issues for decision.
