[Hiring] Senior Manager, Regulatory Affairs @Liquidia

Role Description

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.

• Collaborates closely with Clinical Development/Operations, Safety, CMC, Project Management, and other clinical support functions on submission planning, labeling, and lifecycle management activities.
• Executes regulatory deliverables with sound judgment and helps to drive regulatory readiness to meet business objectives for assigned assets.

Qualifications

• 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.

Requirements

• 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.