Senior Manager, Regulatory Affairs

About Apogee Therapeutics 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!   Role Summary We are seeking a Senior 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 lead the 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. Key Responsibilities Lead and coordinate interactions with project teams, clinical study teams, management, consultants, and collaborators to facilitate timely acceptance/approval of regulatory submissions including INDs, CTAs, NDAs, BLAs, and PIPs/PSPs, among others Support the data collection and cross-functional authorship for regulatory documents. Proofread, edit, and prepare documents for inclusion in regulatory submissions; coordinate with multiple departments to obtain content needed for submissions Communicate timelines for regulatory submissions to individuals and departments and follow up to ensure timely submission Serve as the primary interface with regulatory publishing to ensure compliant electronic submissions to FDA, and ex-US regulatory agencies as needed Appropriately archive and maintain regulatory submissions and correspondences in Apogee’s regulatory information management system Implement and maintain use of standardized templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and advice to team members With mentoring and guidance from the regulatory affairs leadership team, understand and communicate US and international regulatory requirements to ensure quality documents are submitted either directly or in collaboration with a CRO or corporate partner Support global regulatory leads on clinical study and execution teams to ensure that clinical trial deliverables, timelines, and objectives are met Ideal Candidate BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline Regulatory Affairs Certification (RAC) credential preferred A minimum of 5 years of regulatory experience working in drug development in the biopharmaceutical industry Experience interacting with health authorities including FDA and EMA 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 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 $155,000-$175,000. 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.   What We Offer 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   E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this https://www.e-verify.gov/sites/default/files/everify/images/manuals/EVParticipationPoster.JPG.   Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.   To review our privacy policy, https://apogeetherapeutics.com/privacy-policy/   It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.   Offices: (Remote);