What a role map is not
A role map is orientation — not a job description, a competency framework, or a statement of what any employer expects of you.
You have research that might become a product. This is what changes about how you work, and roughly when — before you have a quality team, because the requirements start before the hiring does.
You learn which of your existing records will need to withstand scrutiny later, when GLP begins to apply to safety studies supporting a first-in-human application under ICH M3(R2), what a pre-IND or equivalent scientific-advice meeting is for, and why the manufacturing story matters earlier than most founders expect. Academic laboratory practice and GLP are different standards, and the transition point is a decision rather than a drift.
The expensive mistakes are made early and cheaply: an unrecorded provenance, a cell bank with no history, a comparability gap opened by a process change nobody documented. None of them look like regulatory decisions at the time.
YOUR NEIGHBOURHOOD, IN ONE CONNECTED SYSTEM
At the translation point between research and a regulated development programme, holding responsibilities that have no other owner yet.
- Discovery research and proof of concept
- A first regulatory interaction
- IND-enabling or equivalent non-clinical work
- Contract laboratories and manufacturers for work you cannot do in-house
- External advisers for regulatory route and non-clinical package design
- Institutional agreements governing materials and intellectual property
- Investors and partners underwriting the development plan
- Every later hire who inherits the records made now
- Trial subjects, eventually, whose safety case begins in this work
- The decision about when research practice must become a controlled standard
- Provenance and history of materials, cell banks and reagents
- Selection and oversight of contract organisations, which cannot be delegated away
- Regulatory approval or scientific advice, which the authority gives
- The contract organisation’s own quality system
- Any certification of readiness — no adviser or platform can confer that
- Qualified regulatory and non-clinical advisers before committing to a study design
- An institutional or contract quality unit once one exists
- Research records intended from the start to be reconstructable by someone else
- Material and cell-bank provenance, including donor and source documentation
- Contract-organisation selection rationale and oversight records
WHAT THIS ROLE CAN EVIDENCE · 0
No published competency maps to Founder or Principal Investigator yet. 14 are published across the registry, and this role is not among the ones they name.
Read the standard and its stated coverage →A role map is Locate, moment 2 of 5: what surrounds your work, what you own, and what you escalate. It does not teach the practice or test it. Next is Learn — the Regulatory Affairs pathway. No scenario exercises this role yet, so Practise comes later for it, then what any of it evidences. Skip any of them — the order does not change.
The regulations and standards this pathway anchors on. SPEQ decodes and cites each one; the authoritative text lives at the official source.
- ICH Q12Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle ManagementICH · last revised 2019-11-01
- 21 CFR 314.80Postmarketing Reporting of Adverse Drug ExperiencesFDA · last revised 2023-01-01
- ICH E2B(R3)Electronic Transmission of Individual Case Safety Reports (ICSRs)ICH · last revised 2013-01-01