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5 дней назад

Associate RA Professional EMEA EM - Near East

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
Lebanon
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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