Building a Regulatory Operations Function, Stage by Stage
Building a regulatory operations function
What the function owns, how it differs from regulatory affairs, and what to put in place at each stage — from first-in-human to a commercial, multi-region portfolio.
Regulatory affairs and regulatory operations
Different jobs, often held by the same people early on.
Regulatory affairs owns the strategy and the argument: what to file, when, and what it must say, and the conversation with the agency.
Regulatory operations owns the submission as an object: the plan, the documents, publishing and validation, transmission, and the archive.
What changes as the company grows
People: A regulatory affairs lead, often part-time or consulting; publishing outsourced. Put in place: Document control with approvals; a submission tracker; gateway account. Watch for: Choosing a publishing partner without owning the plan — the partner then decides what goes in each sequence.
People: First regulatory operations hire to own planning, vendor oversight and the archive. Put in place: A real submission plan; a single archive of every sequence sent; correspondence and commitments log. Watch for: Keeping the only copy of the dossier with the publishing vendor.
People: Regulatory operations team of two to five; publishing in-house or hybrid. Put in place: Publishing and validation software, or full visibility into the vendor’s; document templates and PDF standards. Watch for: Deciding to insource publishing for the marketing application itself, under deadline.
People: Regional regulatory leads; labeling; a registration data owner. Put in place: Registration and commitment tracking (RIM), labeling change control, multi-region publishing. Watch for: Post-approval changes and annual reports managed in spreadsheets across markets.
Three records to own from day one
The plan
Every planned sequence, its owner, date and contents — agreed before publishing begins.
The archive
Every sequence ever sent, in its exact form, even when a partner publishes for you.
The commitments
Every agency question and commitment against the application, with a due date and an owner.
And on RIM vs RIMS
The same thing: the record of what you have filed and what has been agreed. Whether the data is complete matters more than the name.
The full guide
For heads of regulatory, regulatory operations leads and biotech leadership.
- Regulatory affairs and regulatory operations — and what RIM is
- The seven processes regulatory operations owns, and what good looks like
- Stage by stage: people, systems, records and the common mistake
- Outsource, insource or hybrid
- Measuring the function, and first steps for a company starting today
Frequently asked
When should a biotech hire its first regulatory operations person?
Usually during Phase 2, when the number of sequences and the vendor oversight exceed what a regulatory affairs lead can do alongside strategy — and before the marketing application, not during it.
Is RIM the same as RIMS?
Yes. Regulatory Information Management, with or without “system” on the end: the record of applications, registrations, submissions, commitments, correspondence and labeling.
Do small companies need RIM software?
They need the records — what is filed, what is approved, what is committed. Early on that can live in a well-kept tracker; it should move into a system before a second region or the first approval, so the data is migrated once.
One platform from first IND to commercial
Submission planning, document management, publishing for 16 eCTD regions, validation, review and registration tracking — so your team owns its plan, archive and commitments from the first sequence.
