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6 дней назад

Regulatory Affairs Manager (Biopharma)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
UAE
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
Regulatory Affairs Manager (Biopharma): Planning and executing regulatory strategies, marketing authorization submissions, and lifecycle management for Amgen products across Gulf markets with an accent on local medicinal-product regulations, labeling, compliance, and health authority interactions. Focus on reviewing promotional materials, patient support programs, digital health solutions, and regulatory intelligence while maintaining accurate submission data and coordinating cross-functional stakeholders.

Location: Dubai, United Arab Emirates

Company

hirify.global is a biotechnology company developing treatments and medicines for patients worldwide.

What you will do

  • Plan and execute regulatory strategies, marketing authorization filings, and lifecycle maintenance activities across five Gulf markets.
  • Align local regulatory requirements with corporate standards and ensure timely, compliant submissions.
  • Review labeling, promotional and non-promotional materials, patient support programs, and digital health or software solutions.
  • Monitor legislation, regulatory guidance, competitive intelligence, pricing intelligence, and distributor or trade association developments.
  • Maintain regulatory data and submission information in Veeva RIM, CPP tools, and regulatory intelligence databases.
  • Act as a contact for health authorities, support agency interactions, advise cross-functional teams, and mentor junior regulatory representatives.

Requirements

  • Bachelor’s degree in pharmacy or a related life science; an advanced degree is advantageous.
  • Typically 4–8+ years of Regulatory Affairs experience, including new product registration and lifecycle management.
  • Knowledge of medicinal-product legislation and registration procedures in the Gulf, including the UAE, Kuwait, Qatar, Oman, and Bahrain.
  • Experience with regulated document and workflow systems such as Veeva Vault and RIM tools.
  • Understanding of drug development and the ability to communicate scientific and clinical information.
  • Strong communication, negotiation, influencing, planning, risk-management, teamwork, and cross-cultural collaboration skills.

Culture & Benefits

  • Collaborative work with local, regional, international, and global regulatory teams.
  • Opportunities to contribute to process improvements, regulatory initiatives, and training.
  • Competitive and comprehensive total rewards aligned with local industry standards.
  • Support for professional growth, personal development, and employee well-being.

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