عربي

الصفحة الرئيسية وظائف في الامارات وظائف أخصائي أول في الإمارات كبار المتخصصين

كبار المتخصصين

Julphar

تم نشره يوم 8 فبراير 2021

3 - 5 سنوات United Arab Emirates - United Arab Emirates

بكالوريوس طب وجراحة (الطب). أي جنسية

سهل التطبيق

عدد الشواغر 01

الوصف الوظيفي

ايميل الوظيفة
تم إرسال البريد الإلكتروني بنجاح.


The role will be responsible for the evaluation dossiers from regulatory perspective as per current guidelines and company requirement for UAE and GCC countries, compilation and submission of new registration dossiers to respective countries as per the registration plan, handle the queries by providing the appropriate responses, as it is required to get the approvals from the health Authorities of different countries, evaluation and identification of documentation gaps during the dossier compilation and communicating with the respective department to full fill requirements, follow up with the concern departments for getting the relevant documents, which are required for our submission, submission UAE dossiers through online system, communication and follow-up with relevant stakeholders for fulfilling requirements of new registration dossier for UAE Marketing authorization and GCC countries
Provide regulatory feedback New registration dossier compilation and submission as per MOH requirements. (MOH online system, CTD & eCTD) , and Maintain internal tracker.
Key responsibilities & Accountability:
Collects & evaluates the Administrative & technical documents required for the submission to different Health Authorities in different countries.
Prepares the Registration Dossiers for the Health Authorities in different countries as per their current guidelines and the preparation of the Technical file for Drug Control Laboratory.
Providing the responses for the queries receiving from the different Health Authorities.
To update product specific information sheet on internal system which comprises of complete approved information related to product at the time of the approval in the related market.
Responsible for the follow up of requested documents from different departments.
Raising change controls for updating the technical documents (raw material specifications, Finished product specifications, Formula & pack declarations etc ) .
Responsible for providing accurate information about regulations to manufacturers and/or scientists.
Archive all the dossiers & Query reponses dispatched to different countries in data management.
Communicate any update in country status to regulatory manager in order to update the tracker.
Create and maintain check list for regulatory requirements for UAE and GCC countries.
Prepare monthly report for achievements.
Qualifications:
- Education
Bachelor of Pharmacy with 5 years experience
- Experience:
At least 3-5 years of related experience in Pharmaceutical field.
- Training:
Key Competencies:
Good written and verbal communication skills.
Time management, Leadership skills.
Technical Competencies:
Excellent scientific & technical knowledge for dossier compilation in CTD and eCTD format.
Good knowledge of MS office (word, excel, power point), Adobe pdf, eCTD software (PharmaReady).


الكلمات الرئيسية

كبار المتخصصين

الدخول للتقدّمسجّل وقدّمقدّم بدون تسجيل

ابلاغ عن هذه الوظيفة

تنبيه: نوكري غلف فقط منصّة يجمع بين كل من الباحثين عن عمل و أصحاب العمل. ننصح المتقدمين للوظائف التحقق من شرعية أصحاب العمل المحتملين. نحن لا ندعم أي مطالبات لتحويل الأموال و ننصح بشدة ضد الإفصاح عن اي معلومات شخصية أو مالية.و ننصح أيضا زيارة تحذير أمني للمزيد من المعلومات. إذا تشك في أي غش أو احتيال اتصل بنا على abuse@naukrigulf.com

Julphar

Established in 1980 in the UAE, Julphar Gulf Pharmaceutical Industries is the largest generic pharmaceutical manufacturer in the Middle East and North Africa. Beginning its journey with the first stand-alone facility that produced 5 products, Julphar now operates 15 globally certified manufacturing facilities. Distributing medicines to more than 40 countries globally, the company maintains a broad range of product portfolio that includes categories such as Pediatric Primary Care, Wound, Anemia and Women Care, Cardiopulmonary Care, Consumer Care, Adult Primary Care, Gastro Care and Pain Management. The company holds the vision to be recognized as the leader for pharmaceutical products and contribute to a better healthcare in the Middle East and Africa region.



Julphar’s 13 facilities are based in the UAE while other manufacturing units are available in Bangladesh, Ethiopia and Saudi Arabia as a part of its international expansion plan. In 2012, the company also launched the only one of its kind Active Pharmaceutical Ingredient (API) manufacturing facility in the Middle East named as Julphar Diabetes, which supported its positioning among the largest manufacturers of insulin in the world. Julphar has bagged several awards and ISO9001 and ISO14001 accreditations. It works closely with regulatory bodies, such as the US Food and Drug Administration (FDA) and the UAE Ministry of Health (MOH) to ensure that all their practices are aligned with the international requirements.



Julphar employs around 3,000 people around the world and believes that its corporate results are achieved due to its dedicated employees. Working for Julphar offers an opportunity for career and personal development.

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