[Hiring] Senior Director, Regulatory Affairs @Pulmovant

Role Description

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.
• 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.
• Participate in due diligence evaluations of potential in-license/partnering opportunities.

Qualifications

• 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.

Company Description

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).

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