Director, Regulatory Affairs

Job overview

The Director, Regulatory Affairs role is onsite in Fremont, CA. Compensation is not specified in the structured pay range; the posting states that base salary starts at $230,000. Nova Pneuma develops product candidates and commercial products requiring regulatory submissions and compliance. The director leads regulatory strategy and submissions from pre-IND through product approval and lifecycle maintenance. The role coordinates cross-functional teams and partners, advises research and commercial teams, serves as a liaison to regulatory authorities, and maintains compliant submission systems and procedures.

What you'll do

• Develop and implement regulatory strategies for product candidates from pre-IND through approval
• collaborate with project teams on compliance throughout product development and lifecycle
• direct regulatory activities for commercial product maintenance
• liaise with regulatory authorities
• support partner submissions and prepare assigned documents
• serve as company pharmacovigilance and drug safety representative
• lead direct reports and advise project teams
• prepare, review, and maintain regulatory submissions and post-market filings
• provide progress updates
• establish SOPs and monitor regulatory changes.

What we're looking for

Skills & competencies

regulatory affairs

director

regulatory strategy

fda submissions

ind

nda

drug-device combination products

pharmacovigilance

fremont ca

nova pneuma

base salary starts at $230,000

biotechnology

Work arrangement

• Weekend coverage required

Benefits & perks

• Comprehensive health and other benefits.

Why this role

Requires 10–12+ years of senior regulatory experience in biotechnology or pharmaceuticals and direct experience with drug/device combination products from pre-IND to NDA. The posting states base salary starts at $230,000 and mentions comprehensive health and other benefits.

About the employer

Nova Pneuma, Inc. is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.