مطلوب مدير تنظيم وتسجيل للعمل لدى إحدى الشركات المتخصصة في قطاع الأدوية
Position: Regulatory and Registration Manager
Industry: Pharmaceuticals
Job Location: Amman, Jordan
Duties and Responsibilities:
- Develop and implement regulatory strategies for the registration, re-registration, and post-approval changes of products.
- Ensure that all products are in compliance with its registration and marketing specifications.
- Direct contact with regulatory bodies to ensure products registration and life cycle.
- Evaluate products registration dossiers with R&D coordination.
- Coordinate with other relevant departments to prepare any necessary document to support products’ registration in Jordan and export markets
- Preparing scientific content to comply with registration requirements for all printed materials for new preparations or for any change in information or printed contents for products that have been registered according to the requirements of regulatory authorities and as permitted by laws related to data protection and others.
- Reviewing change requests and evaluate the impact of the change on the registration status of products in different markets. Or in this way “Review and assess change requests to determine their regulatory impact on product registration status in all relevant markets.
- Constant research and informing all departments about any Update on the regulations or guidelines related to the conformity of products in Jordan and export markets in which the company’s products are marketed.
- Developing and improving methods for controlling registration documents to ensure that information can be consulted immediately and available for follow-up with the concerned authorities.
- Reviewing and approving the results, protocols and reports of products’ stability study to ensure their compliance with the requirements of the registration regulations, licensing and the continuity of the company’s drug license.
- Ensure that annual product reviews are completed according to approved methods to ensure their compliance with applicable requirements.
- Work to develop systems for monitoring side effects and systems for managing medical information related to complaints at the company, in coordination with the Quality Manager and other relevant departments.
- Work closely with internal departments (e.g., R&D, Quality Assurance, Production, Marketing) to ensure regulatory requirements are embedded throughout product development and commercialization.
Job Requirements:
Experience: 10 years of experience in Regulatory and Registration, at least 3 years in managerial role.
Education: BSc. in Pharmacy from a reputable university. (MBA is a plus).
Excellent computer skills in MS Excel and Word.
Fluent in English.
Leadership and Motivational Skills.
Have a car.
qualified candidates are encouraged to submit their resumes to [email protected] mentioning the position in the subject
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تحذير مهم من عمليات الإحتيال
لا تقم بإرسال مبالغ مالية أياً كانت قيمتها لأشخاص أو لأصحاب العمل الذين يعلنون عن وظائفهم الشاغرة على الإنترنت بهدف الحصول على فرصة عمل او تأشيرة للسفر أو أية أمور أخرى. يرجى الإبلاغ عن عملية الإحتيال المشتبه بها واتبع الإجراءات الآمنة للتقدم الى الوظائف على الإنترنت من خلال موقع جوبسلن.