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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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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