Strategic Regulatory Director — IND/NDA Expert

Nova Pneuma, Inc.; Iowa; On-site; USD 207,000 - 253,000; Full time

Job summary

Nova Pneuma, Inc. in Fremont, CA invites an accomplished regulatory affairs leader to drive regulatory strategy from pre-IND to NDA, coordinating with regulatory authorities and cross-functional teams to ensure timely, compliant submissions for product candidates.

You will oversee regulatory documentation, post-market filings, and pharmacovigilance activities while providing leadership to project teams and partners to maintain compliance across the lifecycle of commercial products.

Qualifications

• Experience with FDA submissions (IND/ NDA) and international filings.
• Familiarity with 21 CFR Parts 210,211,820; ISO 13485; EU MDR 2017/745.
• Proven track record authoring regulatory submission documents.
• Strong leadership and ability to lead cross-functional teams.

Responsibilities

• Develop and implement regulatory strategies for successful submission of product candidates from pre-IND through NDA.
• Collaborate with project teams to ensure regulatory compliance throughout product lifecycle.
• Direct regulatory activities for maintenance and compliance of commercial products.
• Serve as liaison for regulatory authorities and external partners.

Skills

FDA submissions

IND/NDA experience

Drug safety/pharmacovigilance

Regulatory strategy

CMC knowledge

Leadership

Cross-functional collaboration

Regulatory documentation

Project management

Regulatory compliance

Education

Bachelor’s degree in scientific field

Advanced degree preferred

Job description

Nova Pneuma, Inc. in Fremont, CA invites an accomplished regulatory affairs leader to drive regulatory strategy from pre-IND to NDA, coordinating with regulatory authorities and cross-functional teams to ensure timely, compliant submissions for product candidates.

You will oversee regulatory documentation, post-market filings, and pharmacovigilance activities while providing leadership to project teams and partners to maintain compliance across the lifecycle of commercial products.