Regulatory Affairs Coordinator

دبي - الإمارات

الراتب شهرياً: لم يكشف

تاريخ النشر: نُشرت قبل 2 ساعة

عدد الوظائف الشاغرة: 1 عدد الوظائف الشاغرة

سجل للتقديم

ملخص الوظيفة

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA) manufacturing and technical teams at the site as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred with an understanding of global CTD requirements.

KEY RESPONSIBILITIES

Collate compile and review regulatory dossiers for product and site registrations in various international markets including GMP audit dossiers.
Ensure accuracy completeness and regulatory compliance of all documentation submitted.
Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.
Act as a key liaison between regional regulatory teams and site-based technical functions (QA QC Production Engineering).
Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.
Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
Implement proper version control submission tracking and document retrieval protocols.
Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
Ensure alignment with both international regulatory expectations and local UAE/GCC requirements.
Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
Support documentation requests for internal audits inspections and compliance reviews.

CANDIDATE EXPERIENCE

Bachelors or masters degree in pharmacy (preferred)
2 to 5 years of experience in Regulatory Affairs ideally in a manufacturing or site-based setting within the pharmaceutical industry.
Preferred: Experience with handling guidelines of UAE Ministry of Health (MoHAP) GCC-DR Oman Bahrain or other Gulf regulatory bodies.
Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation.

Key Skills and Competencies

Strong communication collaboration and coordination skills across technical and regulatory functions.
High level of accuracy attention to detail and document management capabilities.
Ability to manage multiple priorities meet deadlines and adapt to dynamic regulatory requirements.
Proficient in Microsoft Office (Word Excel PowerPoint) and document control systems.
Proactive approach to problem-solving and handling regulatory queries.

KEY RESPONSIBILITIES

Collate compile and review regulatory dossiers for product and site registrations in various international markets including GMP audit dossiers.
Ensure accuracy completeness and regulatory compliance of all documentation submitted.
Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.
Act as a key liaison between regional regulatory teams and site-based technical functions (QA QC Production Engineering).
Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.
Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
Implement proper version control submission tracking and document retrieval protocols.
Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
Ensure alignment with both international regulatory expectations and local UAE/GCC requirements.
Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
Support documentation requests for internal audits inspections and compliance reviews.

CANDIDATE EXPERIENCE

Bachelors or masters degree in pharmacy (preferred)
2 to 5 years of experience in Regulatory Affairs ideally in a manufacturing or site-based setting within the pharmaceutical industry.
Preferred: Experience with handling guidelines of UAE Ministry of Health (MoHAP) GCC-DR Oman Bahrain or other Gulf regulatory bodies.
Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation.

Key Skills and Competencies

Strong communication collaboration and coordination skills across technical and regulatory functions.
High level of accuracy attention to detail and document management capabilities.
Ability to manage multiple priorities meet deadlines and adapt to dynamic regulatory requirements.
Proficient in Microsoft Office (Word Excel PowerPoint) and document control systems.
Proactive approach to problem-solving and handling regulatory queries.

اعرض المزيد

المهارات المطلوبة

مراجعة/ تدقيق/ تنقيح
أدوبي أكروبات
FDA Regulations
Manufacturing & Controls
التكنولوجيا الحيوية
Clinical Trials
البحث والتطوير
GLP
cGMP
تطوير المنتجات
الكيمياء
Writing Skills

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