Senior Manager, Regulatory Affairs

🕒 vor 27 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

🚔 Compliance

👻 Geisterscore 11%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Liquidia Corporation

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2004

🧬 Biotechnologie

💊 Pharmazie

💰 €75.000.000 Post IPO equity im 2024-02

Biotechnology • Pharmaceuticals

Liquidia ist ein biopharmazeutisches Unternehmen, das sich auf die Entwicklung von inhalierbaren Therapien für seltene kardiopulmonale Erkrankungen spezialisiert hat, insbesondere auf die pulmonal arterielle Hypertonie (PAH) und die mit interstitiellen Lungenerkrankungen assoziierte pulmonale Hypertonie (PH-ILD). Das Unternehmen nutzt seine proprietäre PRINT® Partikeltechnologie, um proprietäre Formulierungen und Verabreichungsmethoden zu entwickeln, die darauf abzielen, die Wirksamkeit, Verträglichkeit und Anwendbarkeit von inhalierbaren Medikamenten zu verbessern; Die Produktpipeline umfasst inhalierbares Treprostinil (kommerzielles Produkt) und klinische Kandidaten wie L606. Liquidia legt besonderen Wert auf Patientenunterstützung, klinische Entwicklung und die Verbesserung von Therapien zur Optimierung von Atemwegsergebnissen.

Beschreibung

• Support the development and implementation of global regulatory strategies and contribute to development program planning • Help anticipate changes in the regulatory environment and approval requirements • 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 clinical development and commercialization of drug and delivery device combination products • Prepare 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 postings, 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 and prepare for and participate 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 to regulatory leadership and project teams • Partner with Clinical Development/Operations, Safety, Project Management, CMC, Commercial, and Medical Affairs • Support regulatory activities such as RA-CMC, Device RA, Reg Ops, and AdPromo • Represent Regulatory in study team meetings and escalate issues as appropriate • Support development and implementation of SOPs for regulatory affairs, clinical research/trials, and related activities

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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 employer • Reasonable accommodation for qualified individuals with disabilities