Global Regulatory Strategy Lead for Pharma & Biotech

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

Job summary

AQuestive Therapeutics seeks a Regulatory Affairs Strategist to shape regulatory pathways for pharma products, ensuring timely IND/NDA/CTA submissions and lifecycle management. The role partners across R&D, Clinical, Quality, CMC, and Commercial to align strategies with FDA and global requirements.

Ideal candidates bring advanced life sciences training, substantial regulatory experience, and strong skills in strategy, documentation, and cross-functional leadership, in a fast-paced environment.

Qualifications

• Advanced degree in Life Sciences, PharmD or Regulatory Affairs is 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; track record in filings.

Responsibilities

• Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements.
• Draft and submit regulatory documents (INDs, NDAs, CTAs) to the FDA and international agencies (Canada, Europe, UK).
• Interpret and apply regulations (FDA, ICH, cGMP, USP standards) and monitor changes that may affect product development.
• Provide regulatory guidance to cross-functional teams—R&D, clinical, CMC, quality, and commercial.
• Maintain submission tracking systems, regulatory databases, and filings.
• Interact with regulatory agencies, managing agency correspondence, meetings, and scientific advice requests.
• Identify and mitigate regulatory risks, ensuring compliance and protecting timeline integrity.
• Support global strategies, including alignment with non U.S. jurisdictions where applicable.
• Lead and manage responses to Health Authority information requests.
• Work with CROs, consultants, and the internal team as required to plan, manage, and support regulatory deliverables.
• Interface with senior management to provide project updates.
• Anticipate regulatory risks and propose mitigation strategies.
• Coordinate and prioritize assigned projects according to company goals.

Skills

Regulatory strategy

Cross-functional collaboration

FDA knowledge

Regulatory submissions

Project management

Communication

Education

Advanced degree in Life Sciences/PharmD/Regulatory Affairs

Tools

Submissions platforms

eTMF

Regulatory databases

Job description

AQuestive Therapeutics seeks a Regulatory Affairs Strategist to shape regulatory pathways for pharma products, ensuring timely IND/NDA/CTA submissions and lifecycle management. The role partners across R&D, Clinical, Quality, CMC, and Commercial to align strategies with FDA and global requirements.

Ideal candidates bring advanced life sciences training, substantial regulatory experience, and strong skills in strategy, documentation, and cross-functional leadership, in a fast-paced environment.