Regulatory Affairs Specialist: Personnel Compliance (to Yerevan)

Вакансия № 31522351 в населенном пункте (городе) Ереван, Армения от компании "BostonGene Technologies" на сайте Мультирегиональный Электронный Центр Занятости Населения (ЦЗН).

Логотип (торговая марка, бренд, эмблема, внешний вид здания или внутренний интерьер офиса):

Организация работает в следующих сферах деятельности: Информационные технологии, системная интеграция, интернет; .

Репутация компании "BostonGene Technologies" в отзывах работников:

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Обязательное требование к опыту работы искомого сотрудника: 1–3 года.

График работы: гибкий график.

Тип занятости: полная занятость.

Вакансия № 31522351 добавлена в базу данных: Суббота, 11 мая 2024 года.

Дата обновления этого объявления: Понедельник, 20 мая 2024 года.

Вакансия № 31522351 прочитана - 2 раз(а) Отправлено откликов - 0 раз(а)

Адрес вакантного места работы: Ереван, улица Грачья Кочара, 2А.

Работодатель предложит заработную плату по результатам собеседования с соискателем работы.

BostonGene is seeking a Regulatory Affairs Specialist for Personnel Compliance to join our team. In this role, you will support our personnel's regulatory compliance and training within our organization. You'll have the opportunity to deepen your knowledge of U.S. and international Regulatory Science while working alongside esteemed experts in the field.

Regulatory compliance is important for BostonGene, as it is the key that enables us to perform clinical testing, offer projects to pharmaceutical companies, and be presented in the precision medicine market in the U.S. and other countries. Market approval for different assays can be facilitated by ensuring regulatory adherence and personnel compliance, thereby promoting healthcare innovation and improving oncology patient well-being.

You will organize and optimize processes to ensure adherence to regulatory standards and various clinical laboratory regulations, including GCLP, GCP, and GLP. You will also develop training materials and collaborate with cross-functional teams to ensure compliance with personnel documentation.

Job Tasks and Responsibilities:

• Provide operational support within the team to execute designated tasks associated with regulatory compliance and personnel training compliance;
• Coordinate activities and build processes to ensure assay and personnel training compliance with U.S. regulations (GCLP, GCP, GLP, ISO, etc.), including competency assessments and training;
• Conduct gap assessments of existing documentation against U.S. regulations and maintain compliance documentation for personnel;
• Develop training materials on regulations aimed at enhancing teams understanding and compliance;
• Collaborate closely with cross-functional teams to compile required documentation, ensuring alignment with regulatory standards.

Education and Experience:

• Bachelor’s Degree in Science (Pharmacology, Chemistry, Biology, Medicine) or other relevant domains.
• Experience in Regulatory Affairs, including United States and international medical device regulations is a plus.
• Fast learner with proven ability to adapt to changing demands.
• Excellent problem-solving and analytical skills.
• Ability to work collaboratively in a team environment.
• Fluent in English and Russian, spoken and written.

We offer:

• The office is located in Yerevan, within a 1-minute walk from the metro, and on-site snacks.
• Relocation support for candidates (and their immediate family members) to Armenia.
• 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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