Global Regulatory Strategy Lead – Pharma Submissions

Aequor; New Jersey; On-site; USD 120,000 - 210,000; Full time

Job summary

Aequor Regulatory Affairs is seeking a Regulatory Affairs Strategist to develop and execute regulatory strategies for pharmaceutical products across lifecycle and geographies. You will drive IND/NDA submissions, interactions with FDA and global agencies, and ensure compliance with evolving regulations.

Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, you will provide strategic guidance, manage submission timelines, assess regulatory risk, and support lifecycle

Qualifications

• 5+ years of regulatory affairs experience in pharma/biotech/medical devices.
• Deep knowledge of FDA requirements and global regulations.
• Track record in preparing and submitting regulatory filings.
• Experience with submission platforms, eTMF, and regulatory databases.
• Excellent oral and written communication; cross-functional collaboration.
• Detail oriented, self-starter, entrepreneurial mindset in a fast-paced small company.

Responsibilities

• Develop and implement regulatory strategies across product pipelines (NDAs, BLAs, supplements).
• Draft and submit regulatory documents to the FDA and international agencies (Canada, Europe, UK).
• Interpret FDA, ICH, cGMP, USP standards and monitor regulatory changes.
• Provide regulatory guidance to R&D, clinical, CMC, quality, and commercial teams.
• Maintain submission tracking systems and regulatory databases.
• Interact with regulatory agencies, manage correspondence and meetings.
• Lead and manage responses to Health Authority information requests.
• Coordinate US and EX-US submissions with CROs and internal teams.
• Interface with senior management to provide project updates.
• Anticipate regulatory risks and propose mitigation strategies.
• Align global regulatory strategies with company goals.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

FDA knowledge

Education

Advanced degree in Life Sciences or related

RAC certification

Job description

Aequor Regulatory Affairs is seeking a Regulatory Affairs Strategist to develop and execute regulatory strategies for pharmaceutical products across lifecycle and geographies. You will drive IND/NDA submissions, interactions with FDA and global agencies, and ensure compliance with evolving regulations.

Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, you will provide strategic guidance, manage submission timelines, assess regulatory risk, and support lifecycle