Global Regulatory Strategy Lead for Pharma

Aquestive Therapeutics; New Jersey; On-site; USD 140,000 - 160,000; Full time

Job summary

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist to develop and execute regulatory strategies for drug approvals and lifecycle management. This role serves as a key liaison with regulatory agencies to ensure compliant submissions for clinical trials, marketing authorizations, and post-approval changes.

The candidate will work cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, bringing strong knowledge of FDA IND/NDA processes and global regulations to

Qualifications

• Advanced degree in a scientific discipline required.
• RAC certification is a strong plus.
• 5+ years of regulatory affairs experience in pharma/biotech/medical devices.
• Deep knowledge of FDA requirements and global regulations.
• Experience preparing and submitting regulatory filings.
• Excellent communication and negotiation skills.

Responsibilities

• Develop and implement regulatory strategies across NDAs, BLAs, and supplements.
• Draft and submit regulatory documents (INDs, NDAs, CTAs) to FDA and international agencies.
• Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes.
• Provide regulatory guidance to R&D, clinical, CMC, quality, and commercial teams.
• Maintain submission tracking systems, regulatory databases, and filings.
• Interact with regulatory agencies, manage correspondence, meetings, and advice requests.
• Identify and mitigate regulatory risks, ensuring compliance and timeline integrity.
• Support global regulatory strategies including non-U.S. jurisdictions.
• Lead and manage responses to Health Authority information requests.
• Coordinate with CROs/consultants to plan and support US and EX-US submissions.
• Interface with senior management for project updates.
• Anticipate regulatory risks and propose mitigation strategies.
• Prioritize projects according to company goals.

Skills

Regulatory affairs

Cross-functional collaboration

FDA regulations

Regulatory submissions

Project management

Education

Advanced degree in Life Sciences or related

Tools

eTMF

Regulatory databases

Job description

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist to develop and execute regulatory strategies for drug approvals and lifecycle management. This role serves as a key liaison with regulatory agencies to ensure compliant submissions for clinical trials, marketing authorizations, and post-approval changes.

The candidate will work cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, bringing strong knowledge of FDA IND/NDA processes and global regulations to