Vireo Health is a physician-founded, patient-focused company dedicated to providing best-in-class cannabis-based products and unrivaled care. We integrate best-in-class medical, scientific, and engineering practices into the cannabis industry. We are committed to creating safe, all-natural cannabis-based products and a compassionate patient experience and aim to harness data to further improve the quality, safety and affordability of cannabis-based medicines for our patients.
Vireo Health supports the evidence-based approach to plant medicine and looks to advance the pharmaceutical implementation of complex plant therapies by leveraging robust real-world evidence data sets and reinforcing safety and efficacy claims of plant-based medicine through solid science.
We are currently seeking a full-time Regulatory Affairs Specialist to join our team remotely.
This role will be centered around overseeing and further developing FDA initiatives within the company. The Regulatory Affairs Specialist must be experiences in the development of FDA approved pharmaceuticals, ideally with experience in the botanical realm. The ideal candidate should be able to identify key areas of focus and execute on ideal development path for botanical drug candidates.
- Work with the clinical research team toward furthering efforts in development of FDA botanical drug candidates, formulating strategies to maintain submission goals
- Facilitate new biologics, drugs, botanicals through investigational studies and approval processes
- Spearhead the design, execution, and oversight of eNPV in clinical plan optimization
- Oversee preparation of regulatory submissions in electronic format (ANDA s/NDA s/amendments) to ensure compliance with all FDA regulations and guidelines
- Draft technical documents for regulatory submissions. Provide regulatory review and ensure submissions comply with applicable regulations and guidance documents.
- Establish and maintain contacts and effectively partner with FDA, DEA and other federal agencies to direct, co-ordinate and implement preparation of all regulatory submissions and provide regulatory support across all areas
- Liaise and orchestrate meetings with cross functional departments; strategize and plan for timely submissions
- Plan, execute and lead successful regulatory agency meetings and interactions per regulatory strategy
- Conceptualize the scope of projects and work with the team from project initiation through completion of deliverables
- Work with project teams to identify needs, sources, and structure to further support FDA path botanical candidates
- Utilize large and complex healthcare data (EMR/Seed-2-Sale, Registry Data, Research databases) for the development of RWE support
- With supervision, prepare responses to questions (Information Requests and Complete Response letters) from the FDA
- Review technical documents for submission in new ANDAs, NDAs and provides guidance to the technical development groups.
- Gather, input and compile clinical and non-clinical data, statistics and other materials as needed
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting internal/external team members as necessary
- Participate in activities related to data generation and validation; ensure consistent, quality data review, monitor for clinical data trend identification in collaboration with medical team
- Make recommendations for improving resources (tools, systems, vendors, etc.) needed
- Create effective written reports and communicate findings from the databases to the clinical research team; participate in the production and presentation of deliverables
- Develop creative solutions for complex problems
- Monitor resources/reports to deliver milestones on time and budget
- Maintain strictest confidentiality in compliance with HIPAA guidelines
- Minimum of a Bachelor s degree in a science related discipline, Master degree or higher in pharmaceutical sciences, pharmacology, toxicology, biomedical science, or chemistry preferred
- 5+ years relevant work experience – preferably pharmaceutical industry with specific Regulatory Affairs experience
- Knowledge of Title 21 Code of Federal Regulations (CFR) (GCPs, GLPs GMPs) to ensure FDA regulatory compliance.
- Solid understanding and applied knowledge of regulatory requirements for the development and approval of botanical drugs
- Comprehensive experience in the drug development process in the US and/or abroad
- Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in eCTD format
- Experience reviewing the CMC component of protocols and study reports used in regulatory submissions
- Familiarity with the development and implementation of SOPs and work instructions for processes
- Excellent communication skills, verbal and written.
- Must be 21 years old and pass criminal State background check.
- Excellent work ethic and ability to collaborate with a team.
- High level of integrity and reliability.
Preferred Experience and Skills:
- Proven track record designing and executing creative regulatory development strategies and programs for drugs, biologics/vaccines – experience in rare disease space a plus.
- Must be an independent self-starter. Able to manage multiple tasks, willing to actively seek information necessary to complete assignments.
- Proficient critical thinking, problem solving, decision making skills
- Adaptable and flexible with ability to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
- Possess knowledge about cannabis and how it works with the body, and express interest in furthering one’s education about medical cannabis.
- Exhibits a positive, enthusiastic attitude towards colleagues, patients, and vendors
- Maintain a professional demeanor and appearance and project trustworthiness and maturity.
- Ability to work under tight deadlines in a highly dynamic environment.
- Proficient in Outlook, Microsoft Word, Excel, PowerPoint, Electronic Data Capture or similar data reporting tools, Asana
Equal Opportunity Employer, including disabled and veterans.