Head of Regulatory Affairs and Quality - 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 will begin this year.

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

Summary

The Head of Regulatory Affairs and Quality is responsible for leading the global regulatory and quality strategy and support as a member of a multi-disciplinary team, providing filing expertise in all phases of development. This role is also responsible for developing, implementing, and ensuring compliance with the overall company quality systems.

This role will be a contributing member to the company’s senior management team, managing activities across the regulatory affairs and quality assurance and control organization (GxP).

Key Duties and Responsibilities

• Develop and implement robust regulatory strategy for drug/device combination products.
• Represent Regulatory Affairs in program development teams, providing regulatory guidance and leveraging experience in regulatory affairs, guiding colleagues for preparation of regulatory documents.
• Serve as regulatory affairs contact for external parties (for example, CROs, advisors) involved in the conduct of 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 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.
• Track 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.
• Develop, implement, and maintain robust quality management systems to ensure compliance with GxP requirements for drug substance, drug product, and device in all phases of development.
• Oversee and manage the quality assurance team (internal and/or external), ensuring compliance with all applicable regulations and guidelines, like cGMP, ICH, and FDA requirements.
• Establish and monitor key quality metrics, identify areas for improvement, and implement corrective and preventive actions.
• Provide strategic guidance and leadership in quality-related decision making, risk management, and quality culture development.

Education and Experience

• Advanced degree in a scientific field, plus 15+ years of experience in regulatory affairs.
• Experience in quality assurance or overseeing quality assurance team, preferably in the biopharmaceutical industry, is preferred.
• Experience in drug, device, and drug/device combination global regulatory filings.
• Experience in small molecule therapeutics.
• Understanding of the FDA Division of Cardiology and Nephrology (DCN) is a plus.
• Regulatory Affairs Certification (RAC) in drugs and/or devices is a plus.
• Demonstrated expertise in the design, implementation, and management of quality systems for the development, manufacturing, and release of drug products.
• In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of drug products, including FDA, EMA, cGMP, and ICH requirements.

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.
• Highly proficient using Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint; or similar applications and systems; experience with Veeva is 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!