Senior Manager, Regulatory Affairs

🕒 Outubro 15

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

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Liquidia Corporation

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2004

🧬 Biotecnologia

💊 Farmacêutico

💰 $75.000.000 Post IPO equity em 2024-02

Biotechnology • Pharmaceuticals

A Liquidia é uma empresa biofarmacêutica focada no desenvolvimento de terapias inaladas para doenças cardiopulmonares raras, particularmente hipertensão arterial pulmonar (HAP) e hipertensão pulmonar associada à doença pulmonar intersticial (HP-DPI). A empresa utiliza sua tecnologia proprietária PRINT® de engenharia de partículas para criar formulações e métodos de administração exclusivos, com o objetivo de melhorar a eficácia, tolerabilidade e conveniência dos medicamentos inalados; seu pipeline inclui treprostinil inalado (produto comercial) e candidatos em estágio clínico como o L606. A Liquidia enfatiza o suporte ao paciente, o desenvolvimento clínico e o avanço de terapias para melhorar os resultados respiratórios.

Descrição

• Support the development and implementation of global regulatory strategies and contribute to development program planning • Assist in identifying regulatory pathways and approval requirements for assigned programs, including regional differences • Prepare, review, coordinate, and supervise global regulatory filings executed by CROs across the US, Europe, APAC, LATAM, and other applicable regions • Support filings including INDs/CTAs and amendments; NDAs/MAAs and supplements/variations; regulatory designation requests; and lifecycle management submissions • Draft and coordinate responses to health authority requests • Support alignment of submissions with global eCTD and combination product requirements • Support clinical trial execution requirements, including registry posting development, essential document packages, informed consent reviews, document redactions, translation oversight, and day-to-day regulatory inputs • Oversee routine regulatory submissions, including DSURs/IND Annual Report appendices, NDA Annual Reports, PADERs, and investigator information • Support relationships with regulatory agencies, including preparation for and participation in health authority meetings and interactions • Maintain working knowledge of regulatory policies, guidance, and environments • Build relationships with relevant stakeholders within the assigned disease area • Summarize and communicate health authority correspondence accurately and promptly to regulatory leadership and project teams • Partner with Clinical Development/Operations, Safety, Project Management, CMC, Commercial, and Medical Affairs • Support regulatory activities for assigned assets, including RA-CMC, Device RA, Reg Ops, and AdPromo • Represent Regulatory in study team meetings and escalate issues to regulatory leadership as appropriate • Support the development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities

🎯 Requisitos

• Bachelor's degree in life sciences, engineering, biology, or related field required • Minimum 5 years of industry experience with increasing responsibility in regulatory affairs required • Experience managing regulatory filings and clinical trial execution in the bio-pharma landscape • Experience with a small-to-midsize biotechnology company and/or drug-device combination products preferred • Business travel 10-20% as required • Working knowledge of global regulatory requirements for clinical development and commercialization • Ability to interpret and apply evolving guidance to program execution under the direction of regulatory leadership • Working understanding of drug development and combination product development is a plus • Experience with global regulatory filings, including US FDA and EMA, in support of pre- and post-approval programs • LATAM and Asia experience (i.e., China) a plus • Exposure to global clinical trials and GxP and ISO/EU MDR requirements for combination products • Experience supporting interactions with global regulatory agencies • Experience with document management systems (e.g., Veeva RIM) a plus • Ability to build effective working relationships with internal and external stakeholders • Strong cross-functional collaboration skills with experience supporting alignment in a matrixed environment • Compelling interpersonal, verbal, written, and presentation skills in communication with internal and external stakeholders • Strong organizational skills with the ability to manage multiple deliverables and competing priorities • Sound analytical capabilities in evaluating regulatory risks and supporting mitigation strategies to achieve business goals • High degree of integrity, sound judgment, and commitment to compliance

🏖️ Benefícios

• Competitive compensation package • Medical insurance • Dental insurance • Vision insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) Savings Retirement Plan • Employee Stock Purchase Plan (ESPP) • Equal opportunity employment • Reasonable accommodation for qualified individuals with disabilities

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