Standard operating procedure · RD8A · Research & Development
Regulatory Submission
Transactional procedure owned by Regulatory Science in Research & Development. 8 numbered steps, 3 of them a person deciding and 5 of them agent work … more
Procedure code
RD8A
Transactional
Rule versions in force
v3.3 · v1.4
2 governing rules stacked over it
In force since
2024-09-29
Earliest effective date across those rules
Last reviewed
2026-07-19
Latest review date across those rules
Rules approved by
1
VP Regulatory Science
Rule health
2/2
0 under review · 0 superseded
There is no document register behind this header. The version, the dates and the approver names are read off the governing rules this procedure runs inside, which is the closest thing the estate holds to a document control record. Nobody wrote these procedures. There is no document library behind this page and no Word file anywhere in the estate. Every procedure below is generated from rows this platform already holds: the line and its ordered stations, the owning team and the person accountable for it, the policy items bound to that team, and the governance gates seeded against the function. The steps, the owners, the gates, the approvers, the dwell times and the volumes are read straight off those rows. The sentences that join them together are generated. Read a procedure as the estate describing itself, not as a document somebody signed.
Purpose and scope
What this procedure is for and where it stops
To run regulatory submission to one repeatable standard inside Regulatory Science, part of Research & Development. more
Entry condition
Runs transactional. Starts when a scheduled window opens.
Exit condition
The unit clears track. more
In scope
- Every unit of regulatory submission raised inside Regulatory Science, from the trigger below through to the final step.
- 5 of the 8 steps, which run without a person present.
- 3 decisions that stop the line until a named person releases it.
Out of scope
- Anything outside the envelope set by the owning team. It leaves the line at a gate and becomes the named approver's decision.
- Work that belongs to another function. This line hands off to legal and does not follow the unit there.
- The 2 steps carried on the shared AI GBS spine. They are done for this line but not by this function.
Who owns it
Runs the line
Regulatory Science Orchestrator
Accountable person
VP Regulatory Science
The end of the escalation path. Above them sits R&D Chief of Staff for the function.
That team’s remit
Owns submission work end to end inside Research & Development. more
That remit describes the whole team, not this one procedure, so its counts are larger than the ones on this page.
Autonomy
63% now · ceiling 66%
Requirement mapping and evidence assembly are agentic at scale. more
The procedure, step by step
8 numbered steps · 3 of them stop for a person
A step is one station on the line. more
| No. | Step | Who does it | What happens | System of record | Time on the step | In flight |
|---|---|---|---|---|---|---|
| 01 | Map requirements GBSgbs | Requirement Mapping Agent | Requirement Mapping Agent performs this step unattended on the shared AI GBS transaction spine, outside the function, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 21 minstandard 41 min | 5 |
| 02 | Assemble evidence GBSgbs | Requirement Mapping Agent | Requirement Mapping Agent performs this step unattended on the shared AI GBS transaction spine, outside the function, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 2.8 hrsstandard 4.3 hrs | 38 |
| 03 | Draft dossier Agentworkflow | Submission Drafting Agent | Submission Drafting Agent performs this step unattended at the workflow layer, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 15 minstandard 36 min | 1 |
| 04 | Scientist review HumanpolicyDecision | VP Regulatory Science Releases: VP Regulatory Science | Work stops. VP Regulatory Science reviews what the line has produced and either releases the unit or sends it back. Nothing downstream of this step runs until that decision is made.Holds until: Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged. | Product Lifecycle Management | 5.9 hrsstandard 8.1 hrs | 2 |
| 05 | Counsel review HumanpolicyDecision | VP Regulatory Science Releases: VP Regulatory Science | Work stops. VP Regulatory Science reviews what the line has produced and either releases the unit or sends it back. Nothing downstream of this step runs until that decision is made.Holds until: Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged.Hands off to legal | Product Lifecycle Management | 3.7 hrsstandard 8.7 hrs | 5 |
| 06 | Officer sign HumanpolicyDecision | VP Regulatory Science Releases: VP Regulatory Science | Work stops. VP Regulatory Science reviews what the line has produced and either releases the unit or sends it back. Nothing downstream of this step runs until that decision is made.Holds until: Held for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged. | Product Lifecycle Management | 1.8 hrsstandard 3.5 hrs | 5 |
| 07 | Submit Agentworkflow | Regulatory Science Orchestrator | Regulatory Science Orchestrator performs this step unattended at the workflow layer, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Research Notebook and Experiment Data | 14 minstandard 27 min | 27 |
| 08 | Track Agentworkflow | Requirement Mapping Agent | Requirement Mapping Agent performs this step unattended at the workflow layer, inside the envelope its owning team has set, and writes an evidence record naming the actor, the authority it acted under and the digests of what it read and wrote. | Product Lifecycle Management | 2.1 hrsstandard 4.8 hrs | 24 |
The swimlane
The same steps, laid out by who is holding the work
Three lanes: a person deciding, an agent working, and the shared services spine. more
Run the procedure
One unit walked along that swimlane on the happy viable agentified path
Press run and a single unit enters at station 01. Each station takes exactly the dwell this platform records for it and is held by whoever the estate says holds it. more
Nothing has happened yet. more
- The lanes are the recorded lanes. 3 of the 8 stations stop for a person and every one of them still does on this run.
- Every one of the 3 decisions is still taken by the people who hold them. The happy path is that each one is released first time, not that it is skipped.
- The owning team is held to a 66% autonomy ceiling and this run sits at 34% unattended, inside it.
- 2 systems are attributed across the stations, and 0 of them are connected. Nothing in this run has been watched executing against a real system of record.
1 of the 3 decisions can be handed over inside the 66% ceiling. more
- 05 Counsel review — held by VP Regulatory Science, 3.7 hrs a unit
- 04 Scientist review — Handing this over would put 100% of the worked time in the unattended lane, past the 66% ceiling this team is held to.
- 06 Officer sign — The last decision on the line. Something on every procedure ends with a person, so this one is never offered.
This is a run, not a forecast. more
Happy means nothing goes wrong: no station raises an exception, no gate sends the unit back, no rework loop fires and nothing sits in a queue between stations. more
The second clock is the allowance. more
A decision may be handed to the agent lane only if two things hold … more
The run reads the station rows only. more
What this run does not model: arrival patterns, contention between procedures for the same person, shift patterns, weekends, learning curves, and the cost of anything. more
Run it again, going wrong
The same unit, the same stations, broken the way the estate already records breaking
This is the same unit on the same stations, breaking. more
No break below was chosen. more
One play head, two tracks, the same scale. The clean run stops when it runs out of stations; the other one keeps going.
As written
8 stations, nothing waiting, nothing sent back
0 min of 17 hrs
now Map requirements · Requirement Mapping Agent · 21 min
As the ledger has it
the same stations, plus 7 categories the estate already counts
0 min of 47 hrs
now Map requirements · Requirement Mapping Agent · 21 min
What breaks, and where it is counted
No break below was chosen. more
What the two runs say together
7 counted categories land on this procedure. more
What this run cannot claim
These breaks are shown together on one unit so the shape of a bad day fits on one screen. more
The separation register records a duty conflict against a sub-function and a named post, not against one procedure. more
Attestations on this estate are written against intake items, not against procedures, so a step done off the platform cannot be matched to the attestation that covers it. more
Two clocks run. Worked time is the sum of the time the work is actually being done … more
Roles and responsibilities
5 named parties
The responsibility grid is assigned by a rule, not lifted from a chart. more
| Party | RACI | Steps | Duty | Escalates to |
|---|---|---|---|---|
Regulatory Science Orchestrator orchestrator | Runs the line | 0 | Sequences this line, holds its timetable and decides what has to surface to a person. more | Raises to VP Regulatory Science when a unit falls outside the envelope or confidence drops below the floor. |
Requirement Mapping Agent agent A2% autonomy · ceiling A2% 91% clean · 2% overridden | Responsible | 3 | Runs the repeatable portion of regulatory science inside the shared transaction spine at spine cost and spine controls. | Escalates to VP Regulatory Science when the unit falls outside the decision envelope or confidence drops below the floor. |
Submission Drafting Agent agent A2% autonomy · ceiling A2% 90% clean · 4% overridden | Responsible | 1 | Executes the regulatory science step it owns, posts its evidence, and hands the unit to the next stage. | Escalates to VP Regulatory Science when the unit falls outside the decision envelope or confidence drops below the floor. |
VP Regulatory Science person | Accountable and responsible | 3 | Holds 3 decisions on this line. more | Accountable to VP Regulatory Science for the decisions held here. |
Regulatory Science Orchestrator agent A2% autonomy · ceiling A2% 90% clean · 9% overridden | Responsible | 1 | Owns the regulatory science lane end to end. more | Escalates to VP Regulatory Science when the unit falls outside the decision envelope or confidence drops below the floor. |
Decision points and escalation
3 places this procedure stops
04 · Scientist review
5.9 hrsHeld for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged.
VP Regulatory Science
05 · Counsel review
3.7 hrsHeld for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged.
VP Regulatory Science
06 · Officer sign
1.8 hrsHeld for a named human when the unit exceeds the submission decision envelope, when confidence falls below the floor, or when a policy clause is engaged.
VP Regulatory Science
Handoffs out of this procedure
Step 05 Counsel review passes the work to legal.
The rules this procedure runs inside
2 governing rules
Regulatory Science Decision Envelope
activeRD8-POL-200 · envelope · vv3.3
Agents in this lane may act without a human when the submission sits inside the stated value, risk and confidence envelope. more
Approved by VP Regulatory Science · in force 2024-09-29 · reviewed 2026-05-19
Binds Requirement Mapping Agent, Evidence Assembly Agent, Submission Drafting Agent, Testing Coordination Agent
APAC
Regulatory Science Evidence Standard
activeRD8-POL-201 · evidence · vv1.4
Every autonomous decision writes inputs, the rule version applied, the model and prompt version, the output and a reversal path. more
Approved by VP Regulatory Science · in force 2025-07-16 · reviewed 2026-07-19
Binds Requirement Mapping Agent, Evidence Assembly Agent, Submission Drafting Agent, Testing Coordination Agent
LATAM · US
Systems this procedure touches
2 named · 0 connected
System attribution is a rule, not a reading. more
| System | Vendor | Domain | Criticality | Steps | Connection |
|---|---|---|---|---|---|
| Product Lifecycle Management | Siemens Teamcenter | engineering | high | 7 | modeled |
| Research Notebook and Experiment Data | Benchling | engineering | medium | 1 | not-connected |
0 of the 2 systems on this procedure is connected to the platform, and none of the twenty-six in the estate register is. 0 of them are marked as taking a write back, which is a property of the system, not a live path from here.
How it performs
End to end
17.1 hrs
Summed from the time each step sits, standard 31.1 hrs — running at 55% of the standard.
Touchless
64%
Agent share
63%
A week
7,459
In flight
107
Effort a week
680 human minutes · 343 agent minutes
Volume multiplied by the time on each step. more
Assurance over this procedure
4 governance gates sit above it
The twenty-four controls and eighteen exception classes in this platform are held at estate level … more
| Gate | What trips it | Who releases it | Clock | Waivable |
|---|---|---|---|---|
Physical experiment authorization approval | Any laboratory experiment involving materials, equipment or subjects | Principal investigator and safety officer | 2 business days | No |
External data acquisition approval | Any new external dataset, license or third-party evidence source | Research governance and Legal | 3 business days | No |
Publication or external disclosure approval | Any material leaving the research boundary, including conference abstracts | CSO and General Counsel | 5 business days | No |
Reproduction sampling oversight | Independent re-derivation of 15% of reported internal results | Reproducibility board | Monthly | No |
Next to it on the same team
Regulatory Science
What this document is and is not
These procedures describe the modeled estate. more
Actions
What is waiting on a person
What one procedure document gives you, and what to check before you treat it as the standard.
named approvers appear across the library
Every decision point on every procedure carries a job title, not a queue. more
steps in the library hand their unit to another function
A handoff is where a procedure stops being one team’s problem. more
controls exist in the estate, and they belong to no procedure in particular
Controls and exception classes are held estate-wide. more
Operations
What this desk is allowed to start
A surface that only reports is not operable. more
Trigger and bound
A procedure document prints purpose, scope, entry and exit, the numbered steps with the actor on each, the roles and their RACI position, the swimlane, the decision points and escalation, the handoffs, the governing rules with version and approver, the systems by rule and the timings. more
Live observability
What the record shows right now
The whole library, by lane, so a single document can be read against the estate it came from. more
Current distribution
2,748 steps
Is policy and strategy coming to fruition
Whether the written intent is holding here
Half. The document is complete and every actor on it is measured more
Not holding on the record
A procedure here carries a version, an approver, an in-force date and a last-review date. more