Regulatory Affairs Analyst
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Крайний срок: 18 Май 2024
Условия контракта: Постоянный
Категория: Здоровье/Фармацевтика
Тип вакансии: Полная ставка
Местонахождение: Ереван
Описание работы
We seek an experienced and meticulous Regulatory compliance analyst to join our vibrant team. The ideal candidate will play a crucial role in ensuring our company's compliance with regulatory standards (GCP, GLP, etc) relevant to the biotech industry. This position is integral to our mission of maintaining the highest standards of quality and integrity in our research and development efforts.
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Обязанности
- Regulatory Guidance: Identify the key regulatory requirements applicable to BostonGene's operations and projects. Provide expert advice and guidance on regulatory compliance matters.
- Gap Analysis: Conduct thorough analyses to identify regulatory compliance gaps within the company’s processes and systems. Develop and implement strategic plans to address identified gaps.
- Documentation Preparation: Prepare, review, and maintain critical regulatory documents, including Standard Operating Procedures (SOPs), policies, and guidelines to ensure compliance.
- Continuous Improvement: Monitor changes in regulatory requirements and industry best practices. Update internal policies and procedures accordingly to maintain compliance and improve operational efficiency.
- Collaboration: Work closely with the Regulatory Affairs team and various departments, including Quality Assurance, Research and Development, Clinical Team, etc, to ensure cohesive regulatory compliance efforts across the company.
Требования
- Bachelor’s degree in Life Sciences, Medicine, or related field. Advanced degree preferred.
- Fluent in both English and Russian.
- Excellent written and verbal communication skills, with proficiency in creating clear and comprehensive documentation.
- Detail-oriented with a commitment to accuracy and quality.
- Strong analytical skills and willingness to proactively work with large amounts of regulatory data.
- Experience in preparing SOPs/articles/patents/reports/research protocols.
- Nice to have:
- Experience in regulatory affairs, compliance, or quality assurance within the biotechnology or pharmaceutical industry.
- Familiarity with regulatory requirements and guidelines such as those from the FDA, EMA, or other regulatory bodies.
- Experience in preparing and submitting documentation for regulatory approvals.
- Knowledge of NGS, bioinformatics, immunology, or oncogenesis.
- Publication record.
Требуемый уровень кандидата: Средний уровень
Дополнительная информация
- The office is located in Yerevan, within a 1-minute walk from the metro, and on-site snacks.
- Complete documentation and bureaucracy support on-site (bank accounts, residence permit, school contacts, etc.).
- Full-time position, permanent contract, flexible working hours, hybrid work.
- Competitive salary.
- Healthcare insurance, corporate plans for English language lessons, and gym.
- Versatile professional environment: bioinformatics, biologists, physicians, and software developers who united to save people’s lives.
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