Regulatory Affairs Strategist

Job overview

The Regulatory Affairs Strategist is an onsite, full-time position in Warren, NJ, with an expected base salary of $140,000–$160,000 annually. The role works across R&D, Clinical, Quality, CMC, and Commercial teams to support pharmaceutical product development and lifecycle management at Aquestive Therapeutics. The strategist develops and executes regulatory approaches that support product approvals and ongoing compliance. The role prepares and submits filings, interprets applicable regulations, coordinates with regulatory agencies and internal teams, and identifies risks that could affect compliance or submission timelines.

What you'll do

• Develop and implement regulatory strategies across product pipelines
• draft and submit INDs, NDAs, CTAs, BLAs, supplements, and other regulatory documents
• interpret FDA, ICH, cGMP, and USP requirements
• monitor regulatory changes
• advise cross-functional teams
• maintain submission tracking systems, databases, and filings
• manage agency correspondence, meetings, and information requests
• identify and mitigate regulatory risks
• coordinate regulatory deliverables for U.S. and non-U.S. submissions
• provide project updates to senior management.

What we're looking for

Skills & competencies

regulatory affairs

pharmaceuticals

fda submissions

ind

nda

cta

global regulatory strategy

warren nj

aquestive therapeutics

full-time

salary $140k–$160k

regulatory compliance

Work arrangement

• Weekend coverage required

Why this role

Supports pharmaceutical product approvals and lifecycle management, including submissions to U.S. and international regulatory agencies.

About the employer

Aquestive Therapeutics Inc. is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.