Senior Manager of Regulatory Documentation and Operations, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile.  Enrollment in a phase 2 trial is ongoing.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress.

For more information, please visit https://www.pulmovant.com.

About Roivant:

Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 Vants; 12 consecutive positive Phase 3 trials; 8 FDA approvals; 5 successful IPOs; >$6B in capital raised; >$10B in global pharma partnerships and proceeds; and continued pipeline expansion across various modalities and therapeutic areas through in-licensing and acquisition of novel product candidates and technology platforms.  In addition to a robust clinical stage pipeline, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. 

Position: Senior Manager of Regulatory Documentation and Operations

Summary: 

The Senior Manager of Regulatory Documentation and Operations will be responsible for managing the documentation and regulatory operations infrastructure and overseeing with the regulatory publishing and document management needs for Pulmovant. This position in consultation and alignment with the SVP of regulatory affairs and quality is accountable for all regulatory operations activities. This includes regulatory document formatting and finalization, archiving, submissions planning, publishing, QC, and submissions. The role will require direct hands-on contributions. A successful candidate must have significant experience using Microsoft Word, Adobe PDF, Veeva RIM, and DocuBridge handling a variety of regulatory submissions from early phase through post-approval. US FDA experience is essential, global experience is strongly preferred.

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.

Requirements:

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


• Knowledge of FDA submission expectations is required. Additional experience with ex-US is preferred.


• 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. Preferred if also handled medical device submissions and post-approval 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.