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

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

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

Senior Manager, Regulatory Affairs

Key skills