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Company

Apogee Therapeutics · 2 hours ago

Manager, Regulatory Affairs

United States

Full-time

Remote

Mid Level

$120K/yr - $140K/yr

4+ years exp

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BiotechnologyLife Science

No H1B

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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.

Qualification

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Regulatory Affairs CertificationRegulatory experienceFDA submissionsVeeva RIM platformsECTD submissionsProject managementMicrosoft Office SharePointMicrosoft TeamsCross-functional collaboration

Required

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.

Experience working in Veeva Regulatory Information Management (RIM) platforms, eCTD submissions, and Microsoft Office SharePoint/Teams.

Ability and willingness to travel up to 10%.

Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.

Preferred

Regulatory Affairs Certification (RAC) credential preferred.

Experience interacting with health authorities including FDA and EMA.

Benefits

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