Manager, Regulatory Affairs

Summary

Join Apogee Therapeutics as their Manager, Regulatory Affairs! This newly created role offers a chance to work in a fast-paced environment, contributing to company culture and taking on diverse responsibilities. You will oversee regulatory strategies for Apogee's products, collaborating with project teams and regulatory agencies. This highly visible position involves preparing documentation for FDA and ex-US submissions, serving as the primary interface with regulatory publishing, and representing regulatory affairs on clinical study teams. The ideal candidate will have a BS/MS/PhD in a related field, regulatory experience, and strong communication and project management skills. Apogee offers a competitive compensation and benefits package, including flexible PTO and professional development opportunities.

Requirements

• BS/MS/PhD (or equivalent) in regulatory affairs or related scientific discipline
• A minimum of 4 years of regulatory experience working in drug development in the biopharmaceutical industry
• 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
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Responsibilities

• Interact 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 use of 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

Preferred Qualifications

• Regulatory Affairs Certification (RAC) credential
• Experience interacting with health authorities including FDA and EMA
• Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams
• Ability and willingness to travel up to 10%

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• 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