5 дней назад
Associate RA Professional EMEA EM - Near East
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate RA Professional EMEA EM - Near East (MedTech): Supporting regulatory strategy, product submissions, marketing authorization lifecycle management, and regulatory compliance for Hematology, PAH, and CNS products in Near East countries with an accent on cross-functional collaboration and regulatory dossier coordination. Focus on managing submission timelines, liaising between local operating companies and international groups, responding to health authority requests, and maintaining inspection-ready regulatory records.
Location: Beirut, Lebanon
Company
Johnson & Johnson MedTech develops healthcare solutions designed to prevent, treat, and cure complex diseases while improving patient access to innovative care.
What you will do
- Support regulatory strategy and provide regulatory input to cross-functional teams for Hematology, PAH, and CNS products across Near East countries.
- Execute regulatory plans and manage timelines for submissions, renewals, variations, marketing authorization transfers, and distributor changes.
- Coordinate the preparation, review, submission, tracking, and follow-up of regulatory dossiers in accordance with local requirements.
- Act as the liaison between local operating companies and international groups, managing core dossiers, regulatory statuses, requests, and relevant information.
- Maintain regulatory databases, tracking systems, archives, and marketing authorization lifecycle records.
- Provide regulatory support for health authority responses, packaging materials, promotional materials, importation requests, and clinical trial applications.
Requirements
- Experience or professional capability in regulatory affairs and regulatory product submissions.
- Ability to coordinate regulatory activities across multiple markets and work with international and local stakeholders.
- Knowledge of regulatory dossier preparation, marketing authorization lifecycle management, and local regulatory requirements.
- Ability to support compliance with company policies, standard operating procedures, health care compliance requirements, and applicable laws.
- Ability to maintain accurate regulatory records and support inspection readiness.
Culture & Benefits
- Inclusive work environment that respects diversity, dignity, and individual contribution.
- Cross-functional collaboration with commercial, medical affairs, government affairs, quality, human resources, logistics, and other functions.
- Exposure to regulatory strategy, portfolio management, external stakeholder engagement, and healthcare innovation.
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