Manager - Regulatory Affairs

November 16

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Description

•We are seeking a Manager, 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. Reporting to the Director of Regulatory Affairs, you will have the opportunity to oversee the implementation of regulatory strategies for Apogee’s products in collaboration with project teams and the regulatory affairs department. In this highly visible role, you will facilitate preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will serve as the primary interface with regulatory publishing to ensure timely and compliant submissions and represent regulatory affairs on clinical study and execution teams.

Requirements

•BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline •Regulatory Affairs Certification (RAC) credential preferred •A minimum of 4 years of regulatory experience working in drug development in the biopharmaceutical industry •Experience interacting with health authorities including FDA and EMA (preferred) •Strong project management skills with a high sense of urgency, ability to collaborate and influence effectively cross-functionally •Strong communication skills with an ability to present to a variety of stakeholders and tailor message accordingly •Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams •Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless •Ability and willingness to travel up to 10%

Benefits

•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 •Flexible PTO •Two, one-week company-wide shutdowns each year •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