Senior Manager, Regulatory Affairs

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.