Apogee Therapeutics - Senior Manager, Regulatory Affairs
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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 • 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.
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
Benefits
• 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 poster.
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