The role
You will build, publish and deliver submissions — the operational craft that turns thousands of documents into a valid electronic filing.
What you will do
- Compile, publish and validate eCTD submissions
- Maintain regulatory document management systems and metadata quality
- Track submission and commitment timelines across products
- Support archival, lifecycle and health authority correspondence records
- Improve templates, tooling and process for the regulatory group
What success looks like at 12 months
Submissions validate first time, the RIM system is trusted as accurate, and at least one manual process you inherited no longer exists.
What we require
- Experience with regulatory publishing or document management in a regulated setting
- Meticulous attention to structure, metadata and validation errors
- Comfort with technical systems and troubleshooting
- Ability to work to fixed submission dates
What we would like, but will teach you
- eCTD publishing tool experience
- Veeva Vault RIM familiarity
- Prior document control role
If you meet the required list, apply. We cap the preferred list at four items on purpose, and we would rather read an application from someone who is 70% there and hungry.
Hybrid — onsite at Research Triangle Park, NC three days a week (Tuesday, Wednesday and one team-chosen day).
Pay and rewards
This role sits at grade 6, with a base range of $74,500 – $97,000 for this location, plus annual bonus, retirement contributions of up to 9%, and day-one benefits. See the full package.
About the site
Our clinical development and digital hub. More about our locations.
Accommodations
Need an adjustment to apply or interview? Email accommodations@ingenbiotech.example. It goes to a separate team and is never shared with the hiring manager. What we can arrange.
Applications are not enabled on this demonstration site
On a live InGen careers site this button would open a one-page application: a CV and three short questions, about twelve minutes, no account required and no cover letter.