Senior Regulatory Affairs Manager - Drug-Device Strategy

Liquidia Corporation; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Liquidia Corporation is seeking a Senior Manager, Regulatory Affairs to develop regulatory strategies across rare disease and cardio-pulmonary programs. You will coordinate global filings (INDs/CTAs, NDAs/MAAs) with CROs and lead regulatory submissions while aligning with health authority requirements.

You will collaborate with Clinical Development, Safety, CMC, and Project Management to drive lifecycle management, labeling, and readiness for regulatory submissions worldwide.

Qualifications

• Bachelor's degree in life sciences, engineering, biology, or related field.
• Minimum 5 years of industry experience in regulatory affairs.
• Experience with regulatory filings and clinical trial execution in bio-pharma; drug-device experience preferred.
• Travel 10-20% as required.
• Experience with global regulatory filings including US FDA and EMA; LATAM/Asia experience a plus.

Responsibilities

• Develop and implement global regulatory strategies for assigned programs.
• Prepare, review, and coordinate regulatory filings (INDs/CTAs, NDAs/MAAs) with CROs.
• Draft responses to health authority requests and ensure eCTD alignment.
• Support clinical trial execution and regulatory documentation packages.
• Maintain relationships with global regulatory agencies and participate in meetings.
• Lead regulatory activities within cross-functional teams and SOP development.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Project management

Communication skills

Education

Bachelor's degree in life sciences or related field

Tools

Veeva RIM

Job description

Liquidia Corporation is seeking a Senior Manager, Regulatory Affairs to develop regulatory strategies across rare disease and cardio-pulmonary programs. You will coordinate global filings (INDs/CTAs, NDAs/MAAs) with CROs and lead regulatory submissions while aligning with health authority requirements.

You will collaborate with Clinical Development, Safety, CMC, and Project Management to drive lifecycle management, labeling, and readiness for regulatory submissions worldwide.