The role
You will build and execute regulatory strategy — the plan for how a medicine gets approved and stays approved, and the submissions that make it happen.
What you will do
- Prepare and manage regulatory submissions, amendments and responses
- Develop regulatory strategy in partnership with clinical, CMC and commercial teams
- Interpret guidance and precedent into practical advice for program teams
- Manage agency interactions and meeting preparation
- Maintain regulatory records and ensure compliance with commitments
What success looks like at 12 months
Submissions go out on time and complete, program teams seek your view early in decisions, and an agency interaction has gone well on your preparation.
What we require
- Regulatory affairs experience in pharmaceuticals or biologics
- Understanding of FDA requirements and submission formats
- Ability to give a clear recommendation where guidance is ambiguous
- Strong written communication
What we would like, but will teach you
- Experience of a marketing application or major amendment
- Biologics-specific experience
- RAC certification
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 8, with a base range of $107,000 – $138,000 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.