• Develop and execute a scalable HS&E strategy aligned with company growth objectives. • Serve as a key advisor to executive leadership on risk exposure and mitigation. • Drive year-over-year improvement in TRIR, DART, and EMR performance. • Manage departmental budget and resource planning. • Partner with Operations to integrate safety planning into preconstruction and bid strategy. • Embed HS&E strategy into operational planning to proactively mitigate risk, improve EMR, and drive field execution excellence. • Ensure safety excellence strengthens competitive positioning. • Lead compliance with OSHA, Cal/OSHA, EPA, DOT, PHMSA, and multi-state regulatory requirements. • Oversee company OQ program. • Manage regulatory reporting, audits, inspections, and agency interfaces. • Lead root cause investigations and corrective action implementation. • Conduct field visits to reinforce leadership presence and hazard recognition. • Coach field supervisors on behavioral-based safety. • Lead company safety committees and drive accountability at all levels. • Implement and leverage digital safety management systems. • Develop executive dashboards for real-time performance visibility. • Track, analyze, and report on key safety metrics including TRIR, DART, and EMR. • Utilize leading and lagging indicators to proactively reduce incidents.

Regent University seeks a strategic and relationship-driven fundraising professional to join the Office of Advancement as a Director of Advancement (Major Gift Officer). Reporting to the AVP of Advancement, this individual will play a critical role in advancing Regent's mission by identifying, cultivating, soliciting, and stewarding major gift donors in support of university priorities, including an upcoming capital campaign designed to double residential enrollment to 4,000 students by 2030. The Director of Advancement will manage a portfolio of approximately 100-150 qualified major gift prospects and donors, with primary responsibility for securing five, six, and seven-figure gifts that directly impact student scholarships, academic programs, capital projects, and university operations. This position requires travel, strategic thinking, excellent communication skills, and a demonstrated commitment to Christian higher education. Work Location: Virginia Beach, VA. Qualified candidates may be considered for remote work. Essential Responsibilities: Portfolio Management & Donor Engagement - Manage and grow a portfolio of 100-150 major gift prospects and donors capable of giving $25,000 or more - Conduct face-to-face visits each month with donors and prospects to build meaningful, authentic relationships - Develop and execute individualized cultivation strategies for each prospect, including personalized proposals, impact reports, and stewardship touchpoints - Qualify prospects through strategic discovery conversations, assessing giving capacity, interests, and philanthropic motivations - Move donors through the cultivation cycle from identification to solicitation to stewardship using proven moves management strategies - Close major gifts at the five- and six-figure level annually, meeting or exceeding fundraising goals established by leadership Strategic Fundraising & Campaign Support - Actively support institutional priorities through targeted solicitation efforts - Collaborate with the AVP of Advancement, President's Office, and academic leadership to align donor interests with university needs - Prepare comprehensive briefing materials, customized proposals, and presentation materials for donor meetings - Coordinate with Advancement colleagues on annual giving, planned giving, and corporate/foundation relations to maximize donor engagement - Work with University leadership, Board members, and key volunteers to facilitate peer-to-peer solicitations Donor Stewardship & Relationship Building - Provide exceptional stewardship for all donors in portfolio, ensuring timely and meaningful recognition of gifts - Create customized stewardship plans that demonstrate impact and inspire continued investment - Coordinate campus visits, facility tours, and engagement opportunities that connect donors to Regent's mission - Record all donor interactions, strategies, and contact reports in the donor database (CRM) within 24-48 hours of each meeting - Monitor donor communication preferences and ensure personalized, mission-aligned engagement Collaboration & Institutional Representation - Represent Regent University at donor events, cultivation activities, and fundraising functions, including evenings and weekends as needed - Work collaboratively across departments, including Admissions, Student Life, Academics, and Communications to facilitate donor connections - Stay current on university programs, strategic initiatives, enrollment goals, and institutional achievements to effectively articulate Regent's vision and impact - Participate in professional development opportunities and maintain knowledge of fundraising best practices and trends in Christian higher education Qualifications: - Bachelor's degree from an accredited four-year institution - Minimum of 5 years of professional fundraising experience with demonstrated success in major gift solicitation - Proven track record of personally soliciting and closing gifts of $50,000 or more - Experience managing a donor portfolio and implementing strategic moves management Candidates must have: - Exceptional interpersonal and relationship-building skills with ability to connect authentically with diverse constituencies - Strong written and verbal communication skills, including proposal writing and presentation abilities - Strategic thinking and ability to match donor interests with institutional priorities - Proficiency with donor databases and Microsoft Office Suite - Self-motivated, goal-oriented, and able to work independently with minimal supervision - Excellent organizational skills and attention to detail in managing complex donor relationships - Ability to handle confidential information with discretion and professionalism Faith & Mission Alignment - Committed follower of Jesus Christ with a mature Christian faith and personal relationship with the Lord - Strong commitment to Regent University's mission to provide Christian leadership to change the world - Ability to articulate and represent a Christian worldview in all aspects of the role - Active involvement in a local church community - Background in marketing, sales, or business development preferred - Commitment to Regent’s core values of Excellence, Innovation, and Integrity Physical Requirements & Working Conditions - Travel: Travel required (25% of time), including overnight trips throughout the Mid-Atlantic region and nationally - Schedule: Flexibility required for evening and weekend donor meetings, cultivation events, and university functions - Physical Demands: Ability to sit or stand for extended periods during travel and meetings; occasional lifting of materials up to 25 pounds - Environment: Standard office environment with frequent off-site meetings in donor homes, businesses, and restaurants Benefits Regent offers a wide range of generous benefits including health, life and disability insurance; flexible spending accounts; tuition incentives; fully vested retirement plans; life and disability insurance options, time off, and more. All regular faculty and staff serving at Regent and working a minimum of 30 hours per week will receive an attractive benefits package. To Apply Interested candidates should submit the following materials: - Current resume/CV - Cover letter describing your fundraising philosophy, relevant experience, and alignment with Regent's Christian mission - List of three professional references Applications will be reviewed on a rolling basis until the position is filled. Early applications are encouraged. Regent University does not discriminate in employment in its programs or activities on the basis of race, color, national or ethnic origin, sex, disability, age or veteran status. For full Non-Discrimination Policy click here.

About Us Join us in bringing novel therapies to patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be at their best. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. Through trust, we work seamlessly across functions and take pride in our collaborative working environment! Our vision is to bring unique therapies to patients with rare diseases that extend and improve quality of life. Our focus is on projects in late-stage development for commercialization of treatments for serious diseases with significant unmet medical needs in the orphan drug segment. In February 2025, the European Medicines Agency approved Egetis’ Emcitate® (tiratricol) as the first and only treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome.) In November 2025, Egetis reported positive topline results from the ReTRIACt study of tiratricol in patients with MCT8 deficiency – the final study supporting registration. Following a productive pre-NDA meeting and a Breakthrough Therapy Designation, Egetis plans to begin a rolling NDA submission in December 2025, with completion targeted for early 2026 and a potential FDA decision in Q3 2026 (pending Priority Review). As a committed, courageous and collaborative organization, we are seeking to grow our team to drive success both in the pre-launch and post launch phases of our anticipated US approval. For more information, please visit our website at www.egetis.com or follow us on LinkedIn and Instagram and Facebook About the Job Reporting to the Head of Market Access & Pricing, our Director(s), Market Access Accounts will serve as strategic leaders responsible for securing payer coverage and reimbursement for Egetis Therapeutics’ first rare disease launch in the US. These roles are responsible for ensuring broad access to Egetis’ therapies across assigned accounts including Medicaid, Commercial (Pharmacy Benefit Managers-PBMs), Managed Care Organizations-MCOs, IDN’s , Federal Accounts and Medicare. These roles will focus and develop effective relationships with key decision makers at targeted accounts for the assigned region of the United States. Candidates will have the opportunity to establish the processes and systems necessary to support the role in achieving broad access. The position aims to make a positive impact on patients with rare diseases by facilitating access to life-changing therapies. We are hiring two Directors, Market Access Accounts – one for the East Coast and one for the West Coast. While our U.S. office is based in the Boston area, these are remote positions and candidates may work from anywhere within their assigned region. - Bachelor’s degree required, master’s degree or higher preferred. - 10+ years’ progressive experience in pharmaceutical market access, national accounts, working with Medicaid, national and regional payers, healthcare systems, and Medicare. (Medicaid; rare disease and/or orphan drug launch experience required.) - Proven success leading national payer strategy and negotiating access, pricing, or reimbursement agreements - Experience and comfortability working in a virtual environment including but not limited to; online presentations, scheduling and hosting of virtual meetings with internal/external stakeholders. - Deep understanding of specialty pharmacy, distribution and hub services models with the ability to translate the understanding into a successful business model for an oral, rare disease medication. - Deep understanding of U.S. reimbursement pathways, including coverage, affordability, formulary processes, and value-based contracting - Demonstrate ability to ask strategic questions, craft opportunities and provide fit for purpose solutions to challenges. - Ability to educate and align internal stakeholders that may reside in other countries, excellent communication skills and collaborative work style. - Entrepreneurial mindset, financial acumen, motivated by start-up environment with the ability to deal with ambiguity. - High level of integrity, adaptability, and a mission-driven mindset, aligned with serving patients with severe, underserved rare conditions. - Strong negotiation and communication of value proposition skills. Our Values - Courageous-Challenge the status quo for the benefit of the patient - Committed-Operate with high ethical standards through efficient organization to deliver top quality results. - Collaborative-Through trust, work seamlessly across functions and with external partners. - Develop and Execute account market access strategies and infrastructure designed to achieve optimal coverage, and reimbursement for Egetis therapies with Medicaid, Commercial (Pharmacy Benefit Managers-PBMs), Managed Care Organizations-MCOs, IDN’s, Federal Accounts and Medicare organizations. - Articulate the clinical, economic, and humanistic value proposition of Tiratricol in tailored presentations for key payer audiences and decision-makers. - Foster effective working and strategic senior level relationships at designated target accounts identified and aligned to organizationally as impactful. Cultivate relationships with Key Account influencers shaping reimbursement and policy decisions, including the C suite level to support timely coverage and appropriate authorization criteria to ensure access for Egetis products. - National PBMs - State and Managed Medicaid Plans within aligned geography (e.g. Texas Medicaid, New York Medicaid), - Regional (downstream) accounts - Medicare - IDNs, Kaiser - Indian Health Services, - Veterans Administration - Medicaid: - Work with Medicaid directors, administrators, directors of pharmacy, and policy leaders to drive payer engagement strategies and negotiate contracts where applicable. - Monitor state PDL, participation in disease state clas reviews relevant to Egetis’ therapies including serving as lead for public comment, and state Medicaid pharmacy staff education of Egetis therapies. - Monitor state level regulatory changes and Medicaid policy updates and translate insights into actionable recommendations to adapt market access strategies. - Devise business plans to efficiently achieve access and overcome any barriers. - Effectively lead contract negotiations if applicable. - Analyze national market trends, competitive dynamics and reimbursement landscapes to anticipate barriers and identify opportunities to support patient access to Egetis therapies - Provide strategic insights and reporting to senior leadership on account performance, risks, and evolving payer policies relevant to Egetis therapies. - Drive launch readiness and post-launch execution, including coverage optimization, coding/billing support, formulary pull-through, and access programs. - Provide education on Egetis’ distribution and support services. - Develop comprehensive business updates and account specific plans in alignment with Sales and Marketing priorities. Define clear strategies, tactics and measurable objectives to positively shape payer decision making. Ensure strong cross functional alignment to support optimal account engagement and manage associated budgets budget responsibly. - Collaborate with Commercial, Medical and Patient Support to resolve access and reimbursement issues or concerns. Provide strategic insights to enhance communication of value of Egetis therapies to payers including utilizing and assisting in creation of effective materials. - Partner with assigned Regional Medical Directors (RMDs) to proactively communicate approved disease education messages, unsolicited request or other compliant inquiries. - Participate in regional/national congresses, state association meetings attended by Medicaid as well as select Market Access conferences. - All other duties as assigned. - This is a remote position with travel up to 40-50% domestically or appropriate to optimizing customer relationships for access. Infrequent visit to corporate headquarters in Stockholm, Sweden, possible

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives. Job Summary The Director, Device, Global Regulatory Affairs is responsible for developing and leading global regulatory strategies for the device component of drug-device combination products. This position works with the technical and device strategy team to ensure the device development, verification, validation, and manufacturing activities meet the regulatory requirements in compliance with combination product frameworks (ie 21 CFR Part 4, ISO 13485, EU MDR). The Director provides regulatory leadership across device quality, engineering, human factors, and commercial readiness activities while serving as a key interface with global health authorities and Liquidia’s device manufacturing partners on health authority and device-related topics. Education and Experience - Bachelor’s degree in life sciences, engineering, chemistry, biochemistry, or related field. Advanced degree preferred. RAC or similar certification a plus. - Approximately 12 years of device and combination product regulatory or related experience in the pharmaceutical industry with device regulatory leadership in biotech or pharmaceuticals. Strong preference for experience with inhalation drug-device combination products. - Experience global device regulations, including FDA 21 CFR Parts 4, 820, 801, 803, EU MDR/IVDR, and ISO 13485/14971. - Demonstrated success leading device regulatory submissions and interactions with device-focused regulatory authorities. - Strong knowledge and experience of drug and device development and life cycle management concepts and interdependencies with the overall development process. Knowledge, Skills, and Abilities - Strong understanding of device classification, regulatory pathways, and global device frameworks (PMA, 510(k), Technical Files, CE marking). - Deep knowledge of design controls, risk management, usability engineering, and device quality system requirements. - Familiarity with combination product interfaces, including CMC integration and biologic/device development dependencies. - Working knowledge of global CMC regulatory requirements, ICH guidelines, and technical development considerations. - Ability to provide strategic guidance to cross-functional teams and external vendors. - Strong interpersonal, negotiation, and communication skills with experience presenting to regulators and senior leadership. - Proven ability to lead in a matrix environment while managing multiple programs simultaneously - Demonstrated aptitude for ‘hands-on’ troubleshooting and problem solving with an exemplary history as a “self-starter”. - Strong desire to work as part of many cross-functional teams consisting of technical, quality, clinical, and administrative team members. - Unrelenting dedication to defining strategies to support business objectives and delivering high quality results. - Occasional travel required (<10%). Device Regulatory Strategy and Leadership - Develops and implements global regulatory strategies for the medical device component of the drug-device combination in conjunction with the regulatory team member and other SMEs supporting clinical development and commercialization. - Leads preparation of high-quality Module 2 and Module 3 documentation for INDs, CTAs, BLAs, MAAs, and lifecycle submissions. This includes IMPDs, annual reports, and post-approval changes. - Provides input into design dossiers/technical files (i.e. design history file). - Supports regulatory strategies for applicability of device standards and guidance for the device component of the combination product for manufacturing changes, comparability protocols, and post-approval commitments. - Serves as the primary device regulatory subject matter expert during interactions with the FDA, EMA, and other global health authorities. - Supports responses to health authority questions, specific advice, and regulatory intelligence monitoring. Cross Functional Development and Lifecycle Management - Collaborates closely with Device Strategy, Manufacturing, CMC, Quality, Clinical Development, technical team members, device partners, and vendors to align development and post-marketing activities with global regulatory requirements for filings and maintenance. - Ensures combination product design control activities meet regulatory expectations, including user needs, risk management (ISO 14971), design verification/validation, and DHF/DMR/Technical File readiness. - Supports human factor programs, including study design, protocol review, and regulatory alignment for HF validation studies. - Guides regulatory requirements to combination product cGMP compliance under 21 CFR Part 4. Submission Development and Health Authority Interactions - Leads, authors, and reviews device related documents for health authority filings such as device sections of Module 3, Device Master File components (as applicable). Provides input and review to DHF/Technical File summaries, and human factor engineering reports. - Reviews applicable CMC sections of regulatory submissions (NDA/MAA and supplements, IND/CTA, reports or correspondences, annual reports, IND/CTA amendments) and ensures compliance with regulations and standards of health authorities around the world for assigned programs. - Prepares responses to regulatory authority information requests during the review process to support application approval and maintenance. - Supports teams for health authority meetings. Quality System and Compliance Support - Collaborates with Quality Assurance to ensure device quality system alignment with ISO 13485 and region-specific requirements. - Supports audits, inspections, and readiness activities for device and combination product components. - Participates in developing internal standards, SOPs, and templates for device regulatory activities. Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more! Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Recruiting Agencies, Please Note : Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.