Senior Associate, Regulatory Affairs
About this role
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!
We are seeking a Senior Associate, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. You will have the opportunity to support the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will be a data steward of regulatory information, working closely with Regulatory Operations.
Key Responsibilities
- 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
Ideal Candidate
- 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.
The anticipated salary range for candidates for this role will be $120,000-$135,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
- 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
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