• 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