محتويات الصفحة
Role description:
- Support managing labelling activities within the METAP coverage areas to ensure activities are completed consistently in a timely manner in accordance with internal processes and local and international regulatory requirements.
- Overall scope consists of providing support to Regulatory Affiliate in oversight of all related labelling activities, primarily in:
- Coordination of submission planning, preparation, review, follow-up and implementation of new or modified labeling texts for METAP shared packs and country specific packs.
- Liaison with internal departments and external partners to maintain labeling compliance on market.
- Update current labels to comply with the latest approved labeling product information
- Coordinate the creation or the update of local labeling
- In charge of new product/packs artworks development
- Ensure that changes/new creations are approved and implemented on time to meet HA commitments and internal compliance guidelines while maintaining uninterrupted and optimized supply for operations
- Execute artwork activities in relevant system including proofreading
- Coordinate the review and approval from regulatory, medical and marketing as applicable
- Manage and coordinate local language translations of PIL/labels
- Responsible to perform assessment of the records in TrackWise system for the labeling updates and completion of implementation activities in accordance with HA, company requirements and timelines reporting in the change request action plan
- Controls distribution of correct labels to packaging lines and implementation of correct material in the market
- Track, follow-up and communicate implementation with support of SupplyChain and Quality
- Manage, track and maintain approved labeling materials archives and database.
- Ensuring tracking of regulatory activities in global regulatory tracking tools in accordance with related SOPs
- Create and maintain local procedural documents as needed
- Act as subject matter expert for labeling related activities and procedures and perform regular training as needed
- Identify labeling issues (as errors, inconsistencies and conflicts) between package leaflet and SmPC and take the lead to solve such issues
- Perform any other duties as requested by the management
- Optimize the use of the company resources while fulfilling the above activities
Responsibilities:
1. PLANNING & COMPLIANCE TRACKING
- Track
- Identify, assess and report local regulatory requirements and seek approval from Global Labelling Committee when required
- Maintain labelling history files and old versions of labels by retaining most current versions of Packaging/Prescribing Information Labels
- Update regulatory information systems with submission status
2. AFFILIATE COORDINATION
- Maintain working relationships with defined countries and provides timely and high-quality support as per internal procedure
3. SUBMISSION EXECUTION AND COMPILATION
- Advise Business Partners (Portfolio Expansion Lead, Global Labelling Group) on MEAP local regulatory requirements
- Identify/obtain required documentation and ensure content meets requirements for the registration of labelling changes
- Manage the preparation of registration packages and coordinate additional requests related to deficiency letters, safety-related inquiries and label deviations
- Manage the preparation of the comparative table as needed
- Prepare easy to read English text, coordinate translation and proof-reading for updated/translated labels
- Follow-up on documentation availability, prepare cover letter, application forms and compiles submission dossier accordingly
- Ensure internal approval for the complete submission dossier (Affiliates’ sign-off) prior to filing
- Dispatch and archive submission dossiers
- Coordinate labeling update submissions with regulatory experts and follow-up on approval.
4. OPEN MOCKUP REQUEST FOR ARTWORKS DEVELOPMENT
- Create Mockup Request in compliance with internal procedure
- Provide necessary documentation and masters label
- Ensure label meets local regulation
- Coordinate proof reading and internal sign-off for updated artworks
5. REGULATORY INTELLIGENCE & PROCESS IMPROVEMENT
- Identify and recommend opportunities for improvement to the labelling processes, quality, systems, tools and policies. Benchmark existing processes against external processes
- Implement process improvements
- Regularly monitor, assess, interpret new local regulations and communicate impact accordingly
- Maintain labelling procedures up-to-date
Requirements:
TECHNICAL/FUNCTIONAL SKILLS REQUIRED
- Precision and accuracy in task execution
- Flexibility
- Assiduity and hard working
- Ability to manage multiple projects at the same time and deliver results within deadlines
- Ability to work under pressures and deadlines
- Critical thinking and ability to challenge the status quo
- Strong communication skills
EDUCATION:
- Chemistry, Biochemistry, Pharmacy
- Years of experience: 1-5 years (Regulatory, Labeling, Supply chain)
- Minimum 3 years of relevant experience in Labelling
- Knowledge of labelling requirements procedures, policies and standards
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Regional experience beyond Egypt is highly recommended.
- Detailed oriented, communication, compliance and process Improvement skills.
- Proficiency in English & Arabic languages; French is a highly recommended.
- Computer Knowledge: Knowledge of Agile system & the Office package (Ms Word, Ms Excel, Ms Power Point)
Job Details:
Job/ Career : labeling specialist regulatory affairs
Location : Egypt
Company: Abbott
Category: regulatory affairs
Job posting date : not known
Job closing date: not known
تعليقات مهمة
الوظيفة (الشؤون التنظيمية / أخصائى التسمية أو وضع العلامات فى شركة أبوت) ومتطلبات الوظيفة كالتالى:
المهارات الفنية / الوظيفية المطلوبة
- الدقة في تنفيذ المهام
- المرونة
- الاجتهاد والعمل الجاد
- القدرة على إدارة مشاريع متعددة في نفس الوقت وتقديم النتائج في المواعيد النهائية
- القدرة على العمل تحت الضغوط والمواعيد النهائية
- التفكير النقدي والقدرة على تحدي الوضع الراهن
- مهارات اتصال قوية
التعليم:
- تخصصات الكيمياء ، الكيمياء الحيوية ، الصيدلة
- سنوات الخبرة: ١-٥ سنوات (شؤون تنظيمية - تصنيف - سلسلة إمداد)
- خبرة لا تقل عن ٣ سنوات في مجال وضع العلامات
- معرفة إجراءات وضع العلامات والسياسات والمعايير
- الالتزام القوي بالامتثال للقواعد والإجراءات ذات الصلة والجودة العلمية والنزاهة
- ينصح بشدة الخبرة الإقليمية خارج مصر.
- مهارات مفصلة موجهة ، والتواصل ، والامتثال وتحسين العملية.
- إتقان اللغتين الإنجليزية والعربية. يوصى بشدة بالفرنسية.
- معرفة الكمبيوتر: معرفة نظام Agile وحزمة Office (MS Word ، Ms Excel ، Ms Power Point)
- للمزيد من المعلومات عن الوظيفة >>> نص الإعلان هو الإنجليزى فوق وفيه تفاصيل أكثر
- للتسجيل فى الوظيفة >>> اضغط على زر( التسجيل الآن) بالأسفل
- لزيارة إعلان الوظيفة على الموقع الرسمى للشركة >>> اضغط على زر( التسجيل الآن) بالأسفل
-لمعرفة المزيد من المعلومات عن الشركة >>> اضغط على زر (صفحة المعلومات) بالأسفل
كارت ببعض المعلومات عن شركة أبوت :
مختبرات أبوت (تعرف بالإنجليزية :Abbott Laboratories) هي شركة طبية أمريكية متعددة الجنسيات وشركة رعاية صحية مقرها في مركز أبوت بارك للأعمال في بحيرة بلاف ، إلينوي ، الولايات ...........( لمعرفة المزيد عن زورونا من خلال Meetup بالاسفل )
المقر الرئيسى : مركز أبوت بارك للأعمال في بحيرة بلاف ، إلينوي ، الولايات المتحدة
العنوان فى مصر : اول القاهرة الجديدة، محافظة القاهرة
العنوان فى السعودية : الرياض
العنوان فى الإمارات : دبي - الإمارات العربية المتحدة
مواقع التواصل الاجتماعى الخاصة بهم :
لزيارة الموقع الرسمى للشركة - اضغط على :
للتسجيل فى الوظيفة , اضغط على :
