Associate Director, Regulatory Affairs, 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: Associate Director, Regulatory Affairs Summary: The Associate Director of Regulatory Affairs is responsible for contributing to and executing on global regulatory strategy and support as a member of multi-disciplinary teams. Support the process from development through to approval and ensure compliance with all US and international regulatory requirements. Key Duties And Responsibilities Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documentsServe as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of Pulmovant’s global clinical trialsContribute to the global regulatory strategy for submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, US FDA, EMA, PMDA, ICH, ISO)Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical productsLiaise with global health authorities as agreed with Director of RA and Head of RAContribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risksCommunicate project updates and risks to senior regulatory affairs management and stakeholders across the organizationTrack regulatory deliverables while coordinating with internal and external staff to ensure timely submissionsCoordinate and prepare responses to requests for information from health authoritiesPrepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authoritiesContribute to the development of internal policy and procedures for regulatory affairs in alignment with GxPs, guidance documents, and corporate objectivesMonitor, analyze, and disseminate intelligence on regulatory matters related to your assigned regulatory responsibilities Education And Experience Education equivalent to a BS degree in a scientific field, plus 7 years of experience in regulatory affairs; orEducation equivalent to a MS degree in a scientific field, plus 5 years of experience in regulatory affairs; orEducation equivalent to a PhD/PharmD degree in a scientific field, plus 3 years of experience in regulatory affairsExperience working with the FDA is essential. Additional experience with EU, Japan and other global HAs is strongly preferredExperience with global clinical trials using a CROExperience interacting with the FDA Division of Cardiology and Nephrology strongly preferredExperience with pulmonary hypertension and other pulmonary diseases a plusExperience in drug/device combination products a plusRegulatory Affairs Certification (RAC) in drugs and/or devices a plus Essential Skills And Abilities Unquestionable integrity, being able to inspire trust, and exhibit the highest ethical standardsExcellent communication, verbal and written, and interpersonal skills with a strong ability to interact with internal teams and partners across all levels of the organizationAbility to effectively present information and respond to questions from all levels of the organizationSense of urgency, flawless execution with intense focus on accuracy and accountabilitySelf-starter, highly motivated, assertive, driven, and hands-on leaderAbility to multi-task in a fast-paced environmentOperate collaboratively with colleagues across functional areas in a science-driven environmentAbility to work well under pressure and meet time sensitive deadlinesAbility to work across locations and time zonesHighly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems; experience with Veeva a plusStrong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budgetTravel up to 10% may be required to meet with vendors and regulators Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 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