Senior Director - Regulatory Affairs

February 11

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• The Senior Director, Regulatory Affairs is responsible for developing and implementing global regulatory strategies for Apogee’s portfolio of projects. • This role works closely with cross functional leaders in all regulatory interactions and activities for the development of Apogee’s therapeutic candidates. • The position includes responsibility for the development and refinement of regulatory strategy working in collaboration with senior management, to ensure compliance with applicable global regulations, standards, and clinical practice guidelines. • The position supports interactions with global health authorities and corporate partners with regulatory deliverables. • The incumbent proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, implements regulatory aspects of clinical trials, collaborates with CMC team to ensure regulatory CMC strategies are implemented, and leads development and submission of regulatory documents.

🎯 Requirements

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline • Regulatory Affairs Certification (RAC) credential preferred • A minimum of 10 years of regulatory experience working in drug development in the biopharmaceutical industry, or equivalent based on training and experience • Strong preference for candidates with biologics experience • Experience in inflammatory & immunological therapeutic areas preferred • Strong project management skills with high sense of urgency and the ability to collaborate and influence effectively cross-functionally • Significant experience interacting with major health authorities in the US, EU, and elsewhere • Knowledgeable of pharmaceutical regulations and an ability to identify and interpret legislation, guidelines, and relevant information published by global health authorities • Strong analytical, written and verbal communication skills and ability to present material catered to a variety of target audiences with a broad range of regulatory competency • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless • Detail-oriented with ability and desire to work in a fast-paced, nimble, hands-on, team-oriented, biotech environment • Position requires up to 15% travel

🏖️ 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