Strategic Regulatory Affairs Lead

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

Job summary

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist to lead regulatory strategies supporting approval and lifecycle management of pharmaceutical products. You will liaise with FDA and other agencies to ensure timely submissions for clinical trials, marketing authorizations, and post-approval changes, while guiding cross-functional teams through product development.

The ideal candidate has deep knowledge of FDA requirements, IND/NDA processes, and international regulations, with a

Qualifications

• Advanced degree in Life Sciences, PharmD, Regulatory Affairs, or related.
• 5+ years regulatory affairs experience—pharma, biotech, or medical devices.
• Deep knowledge of FDA requirements and global regulations.
• Track record in preparing and submitting regulatory filings.
• Proficient in project management, communication, and negotiation.
• Experience with submission platforms, eTMF, and regulatory databases.
• Excels at cross-functional collaboration and facilitates effective communication and alignment across diverse teams.

Responsibilities

• Develop & implement regulatory strategies across product pipelines, including NDAs, BLAs, and supplements.
• Draft and submit regulatory documents (e.g. 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 related to US and EX-US submissions for assigned projects.
• 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 affairs expertise

Project management

Communication

Negotiation

FDA regulations

IND/NDA knowledge

Education

Advanced degree in Life Sciences, PharmD, Regulatory Affairs, or related

RAC certification

Tools

Submission platforms

eTMF

Regulatory databases

Job description

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist to lead regulatory strategies supporting approval and lifecycle management of pharmaceutical products. You will liaise with FDA and other agencies to ensure timely submissions for clinical trials, marketing authorizations, and post-approval changes, while guiding cross-functional teams through product development.

The ideal candidate has deep knowledge of FDA requirements, IND/NDA processes, and international regulations, with a