Senior Director, Regulatory Affairs, Pulmovant

Pulmovant is a Roivant-backed clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases. Pulmovant’s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 3 PHrontier global clinical trial in PH-ILD, but with potential broad applicability across the PH and ILD disease landscape.

Pulmovant recently announced positive results from its Phase 2 PHocus study evaluating mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), a progressive and life-threatening condition with significant unmet medical needs for patients. PHocus met both primary and secondary endpoints including the highest ever reported pulmonary vascular resistance (PVR) reduction in any randomized controlled PH trial.

The robust results, in conjunction with mosliciguat’s once-daily, inhaled administration and potential first-in-class sGC activator profile, strongly position it as a potential single agent treatment and combination therapy for patients with PH-ILD.  These data represent a significant advancement in a devastating disease that affects ~200,000 patients with no or very limited treatment options. A Phase 3 trial is currently underway. More details can be found in the press release here.

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 (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody

targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Position:

Senior Director, Regulatory Affairs

Summary

The Senior Director of Regulatory Affairs is responsible for providing global regulatory strategy and support as a member of multi-disciplinary teams. Manage 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 documents

Serve as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of Pulmovant’s global clinical trials

Develop and implement a 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 products

• Liaise with global health authorities as needed
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks
• Communicate project updates and risks to senior regulatory affairs management and stakeholders across the organization
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions
• Coordinate and prepare responses to requests for information from health authorities
• Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
• Provide input into the development of internal policy and procedures for regulatory affairs in alignment with GxPs, guidance documents, and corporate objectives
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
• Participate in due diligence evaluations of potential in-license/partnering opportunities
• Education and Experience
• Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or
• Education equivalent to a MS degree in a scientific field, plus 12-15 years of experience in regulatory affairs; or
• Education equivalent to a PhD/PharmD degree in a scientific field, plus 8 years of experience in regulatory affairs
• Recent experience leading the preparation, submission and approval process for an NDA

Experience working with the FDA is essential.  Additional experience with EU, Japan and other global HAs is strongly preferred.

• Experience interacting with the FDA Division of Cardiology and Nephrology strongly preferred
• Experience with pulmonary hypertension and other pulmonary diseases a plus
• Experience in drug/device combination products a plus
• Regulatory 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 standards
• Excellent communication, verbal and written, and interpersonal skills with a strong ability to interact with internal teams and partners across all levels of the organization
• Ability to effectively present information and respond to questions from all levels of the organization
• Sense of urgency, flawless execution with intense focus on accuracy and accountability
• Self-starter, highly motivated, assertive, driven, and hands-on leader
• Ability to multi-task in a fast-paced environment
• Operate collaboratively with colleagues across functional areas in a science-driven environment
• Ability to work well under pressure and meet time sensitive deadlines
• Ability to work across locations and time zones
• Highly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems; experience with Veeva a plus
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget
• Travel 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.

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!