2 дня назад
Regulatory Affairs Manager - CMC Project Manager
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Affairs Manager - CMC Project Manager (CMC regulatory dossiers): Managing the preparation, review, approval, and submission of CMC response dossiers to health authorities across multiple countries with an accent on document tracking, due-date management, and stakeholder coordination. Focus on resolving technical and regulatory comments, maintaining Veeva Regulatory Vault documentation, and ensuring timely collection of all dossier materials.
Location: New Cairo, Egypt
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Manage trackers for CMC regulatory dossier filings across multiple countries and monitor responses to health authority questions.
- Track document status, due dates, and delivery progress for response dossiers.
- Provide status updates to the dossier authoring team and submission manager.
- Lead weekly progress meetings with technical subject-matter experts.
- Coordinate review and approval timelines, comment resolution meetings, and stakeholder feedback.
- Manage documents in Veeva Regulatory Vault and ensure timely collection of all required materials.
Requirements
- Experience coordinating CMC regulatory dossier delivery and responses to health authority questions.
- Ability to manage document timelines, reviews, approvals, and comment resolution across technical and regulatory stakeholders.
- Experience with Veeva Regulatory Vault or a comparable regulatory document management system.
- Ability to review CMC documentation from development teams and support CMC regulatory requirements.
- Based in New Cairo, Egypt.
Culture & Benefits
- Full-time employment in a global healthcare intelligence and clinical research organization.
- Collaboration with technical, regulatory, dossier authoring, and submission management teams.
- Work focused on supporting the development and commercialization of medical treatments.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →