Global Regulatory Strategy Lead (Pharma)

Regulatory Jobs; New Jersey; On-site; USD 140,000 - 160,000; Full time

Job summary

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist in New Jersey to develop and execute regulatory strategies for pharma products, ensuring timely filings (INDs, NDAs) and lifecycle management. You will liaise with FDA and international agencies and collaborate across R&D, Clinical, Quality, CMC, and Commercial teams.

The ideal candidate has an advanced life sciences degree, 5+ years in regulatory affairs, strong knowledge of FDA requirements, and proven experience with regulatory

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• 5+ years of regulatory affairs experience in pharma, biotech, or medical devices.
• Strong knowledge of FDA requirements and global regulations.
• Experience with regulatory submissions and project management.

Responsibilities

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

Skills

Regulatory strategy

Cross-functional collaboration

FDA regulations

Project management

Communication skills

RAC certification

Education

Advanced degree in Life Sciences/Ph Regulatory Affairs

Job description

Aquestive Therapeutics is seeking a Regulatory Affairs Strategist in New Jersey to develop and execute regulatory strategies for pharma products, ensuring timely filings (INDs, NDAs) and lifecycle management. You will liaise with FDA and international agencies and collaborate across R&D, Clinical, Quality, CMC, and Commercial teams.

The ideal candidate has an advanced life sciences degree, 5+ years in regulatory affairs, strong knowledge of FDA requirements, and proven experience with regulatory