Director of Regulatory Strategy & Submissions

Nova Pneuma, Inc.; Fremont (CA); On-site; USD 207,000 - 253,000; Full time

Job summary

Nova Pneuma, Inc. is a clinical-stage biotechnology company seeking a senior regulatory affairs leader to manage all regulatory activities and counsel R&D and commercial teams.

You will translate regulatory requirements into practical plans and coordinate with partners for submissions. This role requires IND and NDA experience, CDER/CDRH knowledge, and a proven track record leading submissions from pre-IND to approval.

Qualifications

• Experience with IND filings and regulatory submissions for clinical studies.
• IND, NDA submissions experience; NDA a plus.
• Knowledge of CDER, CDRH regulations and GMP.

Responsibilities

• Develop regulatory strategies from pre-IND through NDA submission and product approval.
• Direct regulatory activities for maintenance of commercial products.
• Coordinate regulatory submissions with the FDA and other regulatory agencies; communicate requirements to product teams.
• Collaborate with cross-functional teams to ensure regulatory compliance across filings.
• Maintain IND, NDA and other regulatory submission documents; track interactions.
• Establish and maintain regulatory SOPs and risk assessments.

Skills

FDA submissions

IND filings

NDA experience

CMC knowledge

Regulatory affairs

Partner collaboration

Education

Bachelor's degree in scientific discipline

10 to 12+ years regulatory experience

GMP regulatory environment experience

Job description

Nova Pneuma, Inc. is a clinical-stage biotechnology company seeking a senior regulatory affairs leader to manage all regulatory activities and counsel R&D and commercial teams.

You will translate regulatory requirements into practical plans and coordinate with partners for submissions. This role requires IND and NDA experience, CDER/CDRH knowledge, and a proven track record leading submissions from pre-IND to approval.