Associate Director, Regulatory Affairs

🕒 August 25

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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

• Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams • Guide colleagues in preparing regulatory documents • Serve as regulatory affairs contact for external parties such as CROs and advisors involved in global clinical trials • Contribute to global regulatory strategy for clinical trial and registration submissions under US FDA, EMA, PMDA, ICH, and ISO requirements • Plan, prepare, author, and/or review IND, CTA, BLA, NDA, and MAA submissions and related documentation • Liaise with global health authorities as agreed with regulatory leadership • Develop competitive 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 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 • Contribute to internal Regulatory Affairs policies and procedures aligned with GxPs, guidance documents, and corporate objectives • Monitor, analyze, and disseminate regulatory intelligence

🎯 Requirements

• Education equivalent to a BS degree in a scientific field plus 7 years of experience in regulatory affairs, or an MS degree plus 5 years, or a PhD/PharmD degree plus 3 years • Experience working with the FDA is essential • Additional experience with EU, Japan and other global health authorities is strongly preferred • Experience with global clinical trials using a CRO • 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 and written communication and interpersonal skills • Ability to effectively present information and respond to questions from all levels of the organization • Ability to multi-task in a fast-paced 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 • Unquestionable integrity and highest ethical standards

🏖️ Benefits

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