Registration Senior Officer

الوصف الوظيفي
Job Summary:

Ensure that all SAJA products are compiled/up-to-date with regulatory authorities’ requirements, Oversee and confirm the information received internally and communicated externally with concerned authorities and agents.

Main duties and responsibilities:

- Review/Approve registration files before submission.

- Review technical files of registration files (CTD format, e-CTD format), Renewal files, Extension shelf life and Company registrations/Company Re-registration as well as any regulatory changes.

- Analyse the registration variations and ensure to get approval from regulatory authorities.

- Oversee and confirm the information in the product monograph, label, and finished-product documentation.

- Prepares and submits annual notification of changes.

- Notifies authorities about changes and their implementation.

المهارات
JOB REQUIREMENTS:

* EDUCATION: B.Sc. in Pharmacy or Pharmacy D

* EXPERIENCE: Five to Seven years of related progressive experience.

* KNOWLEDGE & SKILLS:  Strong analytical & evaluation skills, Computer skills (Windows, word and excel), Audit conducting knowledge, and Knowledge of pharmaceutical industry.

تفاصيل الوظيفة
منطقة الوظيفة جدة, المملكة العربية السعودية
قطاع الشركة صناعة الدواء
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي إدارية
نوع التوظيف غير محدد
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة
عدد سنوات الخبرة الحد الأدنى: 5
منطقة الإقامة المملكة العربية السعودية
الشهادة بكالوريوس/ دبلوم عالي

https://www.bayt.com/ar/saudi-arabia/jobs/registration-senior-officer-4455357/