Senior manager, regulatory affairs

Description

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 Senior Manager, Regulatory Affairs supports the development and execution of regulatory strategy throughout clinical development and commercialization for assigned rare disease, cardio-pulmonary drug-device combination product programs. This position works under the direction of the Director/Senior Director, Regulatory Affairs, contributing regulatory expertise across drug and combination product requirements, supporting compliance with global regulations, and helping to prepare and coordinate submissions worldwide. The Senior Manager collaborates closely with Clinical Development/Operations, Safety, CMC, Project Management, and other clinical support functions on submission planning, labeling, and lifecycle management activities. This role supports assigned programs by executing regulatory deliverables with sound judgment and helping to drive regulatory readiness so the company can meet business objectives for its assigned assets.

Requirements

Education and Experience

• 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.

Technical Competencies

• 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.

Leadership and Collaboration

• 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.