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Regulatory Consultant
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:
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Regulatory Expertise:
- Demonstrate a deep understanding of regulatory requirements for novel therapies.
- Provide strategic advice on regulatory pathways and strategies to optimize development timelines.
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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.
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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.
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CRO Engagement:
- Provide guidance on selecting appropriate Contract Research Organizations (CROs).
- Potential to manage CRO relationships.
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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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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