Allucent

Compliance

• At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
• - **Lead regulatory activities and team management**: Assist clients with regulatory aspects of drug, biologic, or medical device products; provide counsel, manage the regulatory team (potentially with direct reports), and translate requirements into practical plans while ensuring timely, scientifically valid submissions.
• - **Oversee HA interactions and project leadership**: Lead/participate in Health Authority communications (e.g., meetings, teleconferences); review/author regulatory content for submissions; contribute expertise on drug/device development as a Leadership team member reporting to Senior Leadership, serving on project teams in roles like Subject Matter Expert or Project Lead.

VP Regulatory Affairs

Director

• **Your main responsibilities will include but not limited to: **
• - Architect and oversee the implementation of advanced IT strategies for data and analytics, ensuring they align with the overall business objectives and scientific goals.
• - Develop and implement the company-wide enterprise architecture & system integration strategy.
• - Communicate complex IT data strategies and insights to a broad range of stakeholders, including non-technical senior management and external partners.
• - Lead the development of secure, scalable, and efficient IT systems and platforms for data collection, storage, processing, and analysis, in compliance with industry standards and regulations.
• - Develop integrations across the business system landscape.
• - Ensure robust data integrity, quality control, and cybersecurity measures are in place to protect sensitive research data.
• - Collaborate with senior management, research teams, and IT staff to ensure seamless integration of analytic capabilities into research and clinical trial processes.

Senior Director, Application Development, Data & Analytics

Vice President

• - Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch
• - Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines
• - Oversee critical development activities including process development, scale-up, manufacturing validation, analytical method development, and packaging/labeling evaluation
• - Manage cross-functional collaboration as a Subject Matter Expert and Technical Lead, partnering with internal teams and external manufacturing partners (CDMOs/CMOs) to ensure seamless program execution
• - Champion quality and compliance by implementing Quality by Design principles, cGMP standards, and risk-based strategies that support clinical trials, regulatory approvals, and commercial success
• - Build and mentor high-performing teams while managing budgets and timelines to deliver robust, scalable, and cost-effective pharmaceutical solutions

VP Regulatory Affairs

Senior Director, Application Development, Data & Analytics

VP CMC, Senior Strategist CMC – Contractor