Apply on Employer Site

Pulmovant · 19 hours ago

Senior Manager of Regulatory Documentation and Operations, Pulmovant

United States

Full-time

Remote

Senior Level

7+ years exp

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. The Senior Manager of Regulatory Documentation and Operations will be responsible for managing the documentation and regulatory operations infrastructure and overseeing the regulatory publishing and document management needs for Pulmovant.

Clinical TrialsHealth CareHealth DiagnosticsMedical

Responsibilities

Able and willing to do hands on document formatting and regulatory publishing

Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements

Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving

Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy

Qualification

Regulatory operationsFDA submission experienceVeeva RIMDocuBridgeDocument formattingPharmaceutical industry experienceVerbal skillsSolution orientedWritten skillsCollaborative team player

Required

BA/BS degree required with 7+ years of pharmaceutical industry experience with 5+ years in regulatory affairs

Knowledge of FDA submission expectations is required

Must be solution oriented

Must be able to handle all aspects of regulatory operations (document and submission processing)

Must have solid experience using Word and PDF files utilizing Veeva RIM and DocuBridge systems

Have successfully completed IND and/or NDA/BLA submissions activities

Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company

Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model

Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company