About Cristcot

We are in the business of addressing the problem within the problem. We focus on the details and connections that other, major pharma companies have left ignored for years. There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Job Summary:

The Director of Regulatory Operations will support Cristcot in its growth by supporting all regulatory needs across the company. This role will lead global regulatory submission management, publishing, and archiving for pharmaceutical and drug-device combination products. This leadership role will ensure compliant, efficient, and timely submissions to global health authorities (FDA, EMA, MHRA, etc.) across all phases of development and post-approval.

Primary Relationships:

• Within Cristcot, the Director of Regulatory Operations will partner with Clinical, Manufacturing, Quality, to ensure submission-readiness and alignment with regulatory timelines.
• Outside Cristcot, the Director of Regulatory Operations will work closely with outside vendors, including but not limited to technical and clinical writing and external publishers. This position will also communicate and coordinate with the FDA.

Primary Job Responsibilities:

The Director of Regulatory Operations will have in-depth knowledge of regulatory systems, global eCTD standards, and experience managing submissions, tracking information and timely correspondence within a highly regulated industry.  he Director of Regulatory Operations will oversee the planning, compilation, publishing, QC, and electronic submission of regulatory documents (eCTD/CTD/NEES) for INDs, NDAs, BLAs, MAAs, amendments, supplements, and annual reports.

The Activities of the Director of Regulatory Operations:

• Manage global regulatory submission calendars and ensure timely execution in alignment with regulatory strategy.
• Maintain and improve regulatory systems, including electronic document management (EDMS), publishing tools (e.g., Liquent, Lorenz, Veeva Vault), and tracking systems.
• Ensure full compliance with evolving global regulatory standards (e.g., FDA ESG, EMA CESP, PMDA, Health Canada, etc.).
• Serve as internal SME for regulatory requirements related to document formatting, structure, and submission best practices.
• Oversee vendor management for publishing, translations, and submission support services as needed.
• Own submission archiving strategy, including compliance with 21 CFR Part 11 and data integrity requirements.
• Ensure lifecycle management of all regulatory documents, including final archival and audit readiness.

Skills and Qualifications:

• Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field (advanced degree preferred).
• 10+ years of Regulatory Operations experience in the pharmaceutical, biotech, or medical device industry.
• Proven track record in planning, managing, and submitting global eCTD regulatory dossiers.
• Deep knowledge of applicable regulations (FDA, EMA, ICH, Health Canada, MHRA) and industry best practices.
• Hands-on experience with eCTD publishing tools and EDMS platforms (e.g., Veeva Vault RIM, Lorenz docuBridge, Extedo, etc.).
• Strong organizational, analytical, and leadership skills.
• Experience with combination products or devices regulated under both FDA/CDER and CDRH.
• PMP certification or experience with complex regulatory project management.
• Familiarity with SPL submissions, XEVMPD, and IDMP initiatives.
• Knowledge of RIM implementation and structured content authoring systems.