Senior Manager, Regulatory Affairs

Apogee Therapeutics is seeking a Senior Manager, Regulatory Affairs to oversee the implementation of regulatory strategies for its products in collaboration with project teams and the regulatory affairs department.

Requirements

• 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

Benefits

• Competitive time off, including three weeks PTO
• Two one-week company-wide shutdowns a year
• Dedicated paid sick leave
• Health, welfare & retirement benefits
• Base salary, performance bonus, equity grant opportunities
• Regular all team, in-person meetings to build relationships and problem solve