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Regulatory Affairs Director
2 months ago
About Evergreen Theragnostics
We are a radiopharmaceutical company headquartered in the United States, operating in a state-of-the-art facility. Our company provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. We also operate our own cutting-edge cancer research laboratories, developing proprietary, radiotherapeutic medicines. Our company expects rapid growth in the next few years.
We are a small team, where all team members support each other in a variety of activities. We are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages are possible.
Key Responsibilities
- Ensure compliance with Health Authority guidelines for NDA/MAA/IND or CTA interactions.
- Manage regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities.
- Support the development of regulatory strategy and update strategy based upon regulatory changes.
- Develop and author submission documents to health authorities from early-phase clinical submissions through to marketing applications and lifecycle activities.
- Oversee and review recommendations and implementation of improvements introduced by new regulations, agency guidance documents, industry standards, new technologies, and internal needs.
- Maintain awareness of science and industry trends and integrate appropriately into work focus.
- Ensure inspection readiness.
- Write/review/approve standard operating procedures, batch records, specifications, validation protocols, and reports, and instrument acquisitions/decommissions, as applicable.
- Support all global Health Authority submission activities (planning, authoring, reviewing, coordination, submission) for projects/products, while applying global strategy to submissions.
- Ensure timely completion, accuracy, and quality of all regulatory and submission documentation across product life cycle.
- Streamline regulatory documentation process and provide strategic guidance and best practices.
- Identify required documentation and any content, quality, and/or timeline issues for global submissions; negotiate the delivery of approved technical source documents in accordance with project timelines.
- Strategically convert scientific data into clear, well-structured, scientifically sound, regulatory documents intended for global health authorities and stakeholders.
Requirements
- 5+ years of pharmaceutical industry regulatory experience.
- Experience directly interacting with FDA and EMA.
- Minimum bachelor's degree, but advanced scientific degree preferred.
- Knowledge of Radiopharmaceuticals a plus.
- Excellent communication and technical writing skills.
- Self-starter with strong problem-solving skills, working on a team of one.
