Pulmovant

Compliance

• 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

Director/Senior Director, Regulatory Affairs

Controller

• Prepare and review monthly, quarterly, and annual financial statements, ensuring compliance with GAAP and internal policies.
• Maintain clinical accruals, including coordination with multiple departments and vendors on a monthly and quarterly basis.
• Manage, mentor, and develop a team of accountants, fostering a culture of continuous improvement and professional growth.
• Assist in the preparation of the annual budget and periodic forecasts, analyzing variances and providing insights to management.
• Design and implement robust internal controls to safeguard assets and ensure the accuracy of financial information.
• Serve as the primary liaison for external auditors; prepare necessary documentation and ensure timely completion of audits.
• Ensure compliance with regulatory requirements and internal policies, including tax regulations and financial reporting standards.
• Work closely with R&D, operations, and other departments to provide financial insights that support business objectives.
• Identify opportunities for process improvements and implement best practices in accounting procedures and systems.

Assistant Controller

Clinical Operations

• Responsible for clinical operations strategy, initiation, and execution of clinical trials, including (but not limited to) CRO/vendor selection, contracts & budgets, CRO/vendor oversight, and proactive risk management to ensure the quality conduct of trials with a high level of quality and data integrity
• Responsible for the successful planning and execution of Phase 2 and 3 trials
• Proactively builds and strengthens site and Investigator relationships and actively cultivates site engagement
• Work cross functionally to drive strategy, oversee the implementation of all clinical programs, and manage the integrated development plans to deliver against company goals
• Proactively identify potential risks and develop and implement actions and plans to avoid or mitigate program risks and make appropriate plan to balance risks, deliverables, and costs
• Lead and supervise all aspects of study progress from concept to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with regulatory guidelines; heavy emphasis on late-stage development experience
• Develops and optimizes critical SOPs needed for program success, inspection readiness and compliance
• Oversee identification, qualification, and selection of CROs and vendors needed to conduct clinical trials including approval of Master Services Agreements and Task Orders with CRO
• Liaise with KOLs, Investigators, and clinical site staff to ensure optimal Sponsor-Site relationships
• Provide scientific/clinical expertise in the design and interpretation of clinical studies
• Ensure effective project or program communications and updates to internal and external stakeholders through meetings, presentations, and other methods
• Provide direct line management and training/mentoring of Clinical Operations team members
• Ensure clinical operation team are trained in regulatory inspection process and develop a pro-active approach for inspection readiness
• Align skills and resources needed for program success; work closely with internal and external stakeholders to leverage and optimize resources
• Create and oversee clinical program budget(s) and long-range clinical planning/forecasting activities
• Ensure there is proper oversight of identified safety concerns and/or adverse events; develop and implement corrective actions accordingly, and participate in internal/external study related audits, as needed
• Contribute as required to the authoring of key regulatory documents, study protocols, investigator’s brochures, IND reports, study postings, ensuring document and operating standards are established and maintained
• Participate in business development and process improvement/quality initiatives, as needed

Head of Clinical Operations

• Able and willing to do hands on document formatting and regulatory publishing.
• Responsible for all documents and submissions to be error free from a regulatory validation standpoint with submissions made on time to meet any internal or external requirements.
• Responsible and accountable for implementing SOPs and work processes for documentation, publishing, submissions and archiving.
• Works with regulatory strategists and CMC strategists and project team members to execute the regulatory strategy.

Director/Senior Director, Regulatory Affairs

Assistant Controller

Head of Clinical Operations

Senior Manager, Regulatory Documentation and Operations