Regulatory Affairs Director — Pharma Strategy & Submissions

Pelthos Therapeutics Inc.; Durham, Northern (NC, KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Pelthos Therapeutics Inc. is seeking a Director, Regulatory Affairs to develop and lead regulatory strategies for drug development, registrations, and post-approval activities.

You will manage submissions, coordinate with cross-functional teams, and serve as the main liaison with regulatory authorities including the FDA. The role emphasizes publishing, documenting, and ensuring compliance with evolving regulatory requirements while enabling timely product approvals.

Qualifications

• MS or advanced degree in chemistry, biology, or biomedical related field.
• 10+ years of drug regulatory affairs experience.
• Hands-on experience with INDs and NDAs.
• Direct FDA interaction experience.
• Knowledge of FDA Dermatology/Anti-Infectives divisions is a plus.

Responsibilities

• Lead content management and publishing for regulatory documents.
• Develop and execute regulatory strategies for drug development and post-approval activities.
• Manage submission plans and coordinate development activities with the submission processes.
• Identify process improvements for internal systems related to publications and archiving of regulatory records.
• Serve as primary contact for interactions with regulatory agencies such as the FDA.
• Monitor regulatory changes and provide guidance to internal stakeholders.

Skills

Regulatory strategy

FDA interactions

IND/NDAs

Cross-functional collaboration

Project management

Regulatory submissions

Process improvement

Strategic thinking

Documentation publishing

Regulatory compliance

Education

MS or higher in chemistry/biology/biomedical field

Job description

Pelthos Therapeutics Inc. is seeking a Director, Regulatory Affairs to develop and lead regulatory strategies for drug development, registrations, and post-approval activities.

You will manage submissions, coordinate with cross-functional teams, and serve as the main liaison with regulatory authorities including the FDA. The role emphasizes publishing, documenting, and ensuring compliance with evolving regulatory requirements while enabling timely product approvals.