Global Regulatory Strategy Lead for Pharma

Aquestive-Therapeutics-Inc; Warren Township (NJ); On-site; USD 140,000 - 160,000; Full time

Job summary

Aquestive Therapeutics, Inc. is seeking a Regulatory Affairs Strategist in Warren, NJ to develop and execute regulatory strategies supporting approval and lifecycle management of pharmaceutical products.

You will coordinate with R&D, Clinical, Quality, CMC, and Commercial teams and ensure timely submissions for clinical trials, marketing authorizations, and post-approval changes. Ideal candidates will have deep FDA regulation knowledge, experience with IND/NDA processes, and a track record in

Qualifications

• Advanced degree in a scientific discipline required (Life Sciences, PharmD, Regulatory Affairs, or related).
• RAC certification is a strong plus.
• 5+ years of 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.
• Excellent oral and written communication skills.
• Experience developing and implementing successful regulatory strategies.
• The candidate should be detail oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

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 strategy

Cross-functional collaboration

Project management

Communication

Negotiation

Education

Advanced degree in Life Sciences/PharmD/Regulatory Affairs

Tools

Submission platforms

eTMF

Regulatory databases

Job description

Aquestive Therapeutics, Inc. is seeking a Regulatory Affairs Strategist in Warren, NJ to develop and execute regulatory strategies supporting approval and lifecycle management of pharmaceutical products.

You will coordinate with R&D, Clinical, Quality, CMC, and Commercial teams and ensure timely submissions for clinical trials, marketing authorizations, and post-approval changes. Ideal candidates will have deep FDA regulation knowledge, experience with IND/NDA processes, and a track record in