Senior Director, Regulatory Affairs

🕒 September 25

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 25%

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Pulmovant

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Pulmovant is a company committed to transforming the lives of patients with pulmonary diseases by developing innovative therapies. Their lead product, mosliciguat, aims to provide a once-daily, inhaled treatment for pulmonary hypertension, distinguished by its novel sGC activation mechanism. With a singular focus on addressing the unique needs of patients suffering from pulmonary conditions, Pulmovant is engaged in extensive clinical trials to advance its pioneering treatment options.

📋 Description

• Provide global regulatory strategy and support as a member of multidisciplinary teams • Manage regulatory processes from development through approval and ensure compliance with US and international regulatory requirements • Represent Regulatory Affairs in project meetings and provide regulatory guidance to cross-functional teams • Serve as regulatory affairs contact for external parties, including CROs and advisors, involved in global clinical trials • Develop and implement global regulatory strategies for clinical-trial submissions and registration under applicable regulations and guidelines, including US FDA, EMA, PMDA, ICH, and ISO • Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions and related documentation • Liaise with global health authorities • Contribute to regulatory strategies that expedite development, maximize success probability, and mitigate risks • Communicate project updates and risks to senior regulatory affairs management and organizational stakeholders • Track regulatory commitments and deliverables and coordinate internal and external staff for timely submissions • Coordinate and prepare responses to health-authority information requests • Prepare meeting requests and briefing documents and coordinate teams for health-authority meetings • Provide input into regulatory policies and procedures aligned with GxPs, guidance documents, and corporate objectives • Monitor, analyze, and disseminate regulatory intelligence affecting development programs • Participate in due diligence evaluations of potential in-license and partnering opportunities

🎯 Requirements

• Education equivalent to a BS degree in a scientific field, plus 15+ years of experience in regulatory affairs; or education equivalent to an 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 health authorities 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 • Excellent verbal, written, communication, interpersonal, presentation, and collaboration skills • Ability to multitask in a fast-paced environment and work under pressure while meeting time-sensitive deadlines • Ability to work across locations and time zones • Highly proficient in Microsoft Word, Excel, PowerPoint, Adobe, and SharePoint or similar applications and systems; Veeva experience a plus • Strong financial business acumen and analytical skills, including managing expenditures within budget • Ability to travel up to 10%

🏖️ Benefits

• Equal employment opportunities and protection from discrimination and harassment • Travel up to 10% may be required to meet with vendors and regulators

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