6 дней назад
Regulatory Affairs Manager (Biopharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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