Senior Regulatory Affairs Leader - Drug/Device Submissions

Nova Pneuma, Inc.; Fremont (CA); Presencial; USD 195 000 - 265 000; Tempo integral

Resumo da oferta

Nova Pneuma, Inc. is seeking a senior Regulatory Affairs leader to manage all regulatory activities from pre-IND through NDA, ensuring compliant strategies and timely submissions.

You will collaborate with R&D, PV, and commercial teams, liaise with regulators, and oversee documentation across global programs. You will provide regulatory leadership, drive strategies for drug-device combinations, and guide teams on complex regulatory requirements to accelerate development and post-market

Qualificações

• Bachelor’s degree in scientific discipline or commensurate experience.
• 10–12+ years senior regulatory experience in biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug/device combinations.
• Experience with IND/NDA submissions and regulatory support for commercial products (NDA) is a plus.
• Familiarity with 21 CFR Part 210, 211, 820; ISO 13485; EU MDR 2017/745 and related standards.
• Strong written and verbal communication, leadership, and cross-functional collaboration.
• Experience in GMP-regulated environments and regulatory certification preferred.

Responsabilidades

• Develop regulatory strategies for IND through NDA submissions.
• Collaborate with project teams to ensure regulatory compliance throughout product lifecycle.
• Direct regulatory activities for maintenance and post-market requirements.
• Serve as liaison for regulatory authorities and external partners.
• Prepare regulatory submissions (IND, NDA, Technical File) with cross-functional data.
• Maintain regulatory document systems and track interactions.
• Provide updates toExecutive Team and project teams; establish SOPs.

Conhecimentos

FDA submissions

IND filing

NDA experience

Pharmacovigilance

Global submissions

Regulatory leadership

Cross-functional

Regulatory standards

Project mgmt

Drug-device combos

Formação académica

Bachelor's degree in science

10+ years regulatory experience

Advanced degree preferred

Descrição da oferta de emprego

Nova Pneuma, Inc. is seeking a senior Regulatory Affairs leader to manage all regulatory activities from pre-IND through NDA, ensuring compliant strategies and timely submissions.

You will collaborate with R&D, PV, and commercial teams, liaise with regulators, and oversee documentation across global programs. You will provide regulatory leadership, drive strategies for drug-device combinations, and guide teams on complex regulatory requirements to accelerate development and post-market