Senior Associate, Regulatory Affairs

Apogee Therapeutics

Senior Associate in Regulatory Affairs supporting FDA submissions and regulatory documentation for biotech company. Working in a fast-paced environment, coordinating with cross-functional teams.

Posted 5/6/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $120,000 - $135,000 per yearWebsite

About the role

Key responsibilities & impact

Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness
Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards
Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones
Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation
Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments)
Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness
Support inspection readiness activities (e.g., TMF health checks, document completeness reviews)
Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

Requirements

What you’ll need

BS (or equivalent) in related scientific discipline
2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred)
Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently
Strong written and verbal communication skills to clearly convey operational considerations and collaborate effectively with internal and external stakeholders
Proven proficiency in MS Word, Excel, Power Point; SharePoint/Teams (preferred)
Experience working in Veeva Regulatory Information Management (RIM) platform and eCTD submissions (preferred)
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 10% travel including mandatory in-person attendance at All Hands meetings typically held twice per year.

Benefits

Comp & perks

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory data managementsubmission trackingquality control (QC)eCTD submissionsregulatory submissions preparationdocument completeness reviewsinspection readiness activitiestimelines managementdata accuracydata completeness

Soft Skills

organizational skillsattention to detailmultitaskingwritten communicationverbal communicationcollaborationstakeholder engagementagenda developmentcoordinationdocumentation

Certifications

BS in related scientific discipline