Regulatory Strategy Lead, Pharma (IND/NDA)

Aquestive Therapeutics, Inc.; Northern (KY); Hybrid; USD 140,000 - 160,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Warren, NJ seeks a Regulatory Affairs Strategist to develop and execute regulatory strategies that support product approvals and lifecycle management.

The role requires FDA knowledge, coordination with R&D, Quality, CMC and Commercial teams, preparation of INDs/NDAs/CTAs, and interaction with health authorities worldwide. The candidate should have an advanced degree, RAC is a plus, 5+ years in regulatory affairs, and strong communication and project management

Qualifications

• Advanced degree in Life Sciences or Regulatory Affairs.
• 5+ years regulatory affairs experience in pharma/biotech.
• Strong knowledge of FDA requirements and global regulations.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Develop and implement regulatory strategies across product pipelines.
• Draft and submit INDs, NDAs, CTAs to FDA and international agencies.
• Interpret and apply FDA/ICH regulations and monitor changes.
• Provide regulatory guidance to cross-functional teams.
• Maintain submission tracking systems and filings.
• Interface with senior management for project updates.

Skills

Regulatory affairs

FDA regulations

Project management

Cross-functional collaboration

Communication

Education

Advanced degree in Life Sciences/Regulatory Affairs

Tools

eTMF

Regulatory databases

Submission platforms

Job description

Aquestive Therapeutics, Inc. in Warren, NJ seeks a Regulatory Affairs Strategist to develop and execute regulatory strategies that support product approvals and lifecycle management.

The role requires FDA knowledge, coordination with R&D, Quality, CMC and Commercial teams, preparation of INDs/NDAs/CTAs, and interaction with health authorities worldwide. The candidate should have an advanced degree, RAC is a plus, 5+ years in regulatory affairs, and strong communication and project management