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Executive Consultant: Regulatory Affairs (VP)

Menlo Park, CA 94025

Posted: 09/22/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 585785 Is job remote?: Yes Country: United States

Job Description

We are looking to engage an Executive Regulatory Consultant to support the clinical development strategy for a stealth mode biotechnology company specialized in the Alzheimer's and rare neurodegenerative space. The company is nearing completion of a robust Phase 2 study and gearing up for Phase 3. 

Location: Remote / Virtual
Engagement: Fractional PT Consultant / 1099 preferred, Part-Time Hours can vary dependent on Consultant capacity available.  
Experience: Must have deep Neuro / Alzheimers (AD) expertise and experience with rare / orphan neurodegenerative a plus. 

The intended scope of work can include: 

  1. Regulatory Strategy and Compliance Expertise:
    • Prepare for end of phase 2 meeting with FDA (clinical data / plan and commercially viable formulation).  The manuscript for the phase 2 data is in the final stages of completion.
    • Leverage extensive knowledge of recent regulatory trends and guidelines in the rare neurodegenerative space to develop and execute robust regulatory strategies for Phase 3 trials and beyond.

  2. Rare Neuro Focus: Specialized Insight:
    • Provide subject matter expertise in rare neurodegenerative diseases, staying updated with the latest advancements and regulatory nuances specific to this therapeutic area.

  3. Phase 3 Trial Planning and Execution:
    • Collaborate closely with the clinical and development teams to ensure regulatory compliance throughout the Phase 3 trial process, including protocol design, submission planning, and interactions with regulatory authorities.

  4. Preparation and Submission of Regulatory Documents:
    • Handle the preparation and submission of high-quality regulatory documents, including INDs, briefing packages, and marketing authorization applications.

  5. Regulatory Intelligence and Risk Management:
    • Stay abreast of evolving regulatory landscapes, providing proactive advice on potential risks and opportunities for the company's rare neurodegenerative program. Strategically mitigate regulatory hurdles to support successful outcomes.
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