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Regulatory Consultant

New York, NY 10001

Posted: 10/04/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 614911 Is job remote?: Yes Country: United States

Job Description


Project Objective: To provide expert regulatory guidance and support for a preclinical biotechnology company developing an oncolytic virus therapy.

Time Commitment: Approximately 10-20 hours per week.

Location: Remote.

Consultant Responsibilities:

  1. Regulatory Expertise:
    • Demonstrate a deep understanding of regulatory requirements for novel therapies.
    • Provide strategic advice on regulatory pathways and strategies to optimize development timelines.

  2. Pre-IND Guidance:
    • Lead the preparation of pre-IND submissions, including the application, briefing book, and supporting documents.
    • Conduct thorough assessment of preclinical data and safety profiles.
    • Collaborate with internal teams to gather necessary information and address regulatory questions.

  3. Cost and Timeline Estimation:
    • Develop realistic estimates or provide guidance for study costs, timelines, and resource requirements.
    • Based on cost and timeline estimation, to provide advice to CEO on necessary capital needs.

  4. CRO Engagement:
    • Provide guidance on selecting appropriate Contract Research Organizations (CROs).
    • Potential to manage CRO relationships.

  5. Regulatory Briefing Book Preparation:
    • Develop a comprehensive briefing book for regulatory meetings, including summaries of preclinical data, safety assessments, and proposed clinical development plans.

Note: This scope of work is intended as a high-level guideline and can be adjusted based on the specific needs of the company and the consultant. Regular communication and collaboration will be essential for successful project 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 Planet Pharma, 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.