Global Regulatory Strategy Lead - 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 pharmaceutical products, serving as a liaison with regulatory agencies.

The role requires strong knowledge of FDA IND/NDA processes, international regulations, and experience preparing regulatory documentation. Collaboration with R&D, Clinical, Quality, CMC, and Commercial teams is essential.

Qualifications

• Advanced degree in Life Sciences, PharmD, Regulatory Affairs, or related field.
• RAC certification is a strong plus.
• 5+ years of regulatory affairs experience in pharma, biotech, or medical devices.
• Deep knowledge of FDA requirements and global regulations; track record of regulatory filings.

Responsibilities

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

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Communication

Project management

Education

Advanced degree in Life Sciences/Pharma/Regulatory Affairs

RAC certification (preferred)

Tools

eTMF

Regulatory submission platforms

Job description

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist to develop and execute regulatory strategies for pharmaceutical products, serving as a liaison with regulatory agencies.

The role requires strong knowledge of FDA IND/NDA processes, international regulations, and experience preparing regulatory documentation. Collaboration with R&D, Clinical, Quality, CMC, and Commercial teams is essential.