Associate Regulatory Affairs Mea
6 days ago
Career Category
Regulatory
**Job Description**:
Job Summary:
- Labeling and packaging activities management for Middle East North African region for Amgen portfolio
- Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting.
Key Activities:
- Systems Management to deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
- Performance Excellence Management through collection, analyzing & disseminating relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Build & share newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
- Intelligence Gathering
- Perform Publishing and System driven activities
- Ensure delivery of right first time label source text for artwork creation
- Support efficiently products life cycle management by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
- Perform label management within the system from CDS (product core data sheet) update to variation submission in the region
- Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
- Access the translation agency systems to request the label translation and track the job readiness and timelines.
- Perform regional prescribing information translation review: 100% review of both content and format
- Perform the role of source text owner/approver and artwork reviewer/approver in the system
- Trigger the existing label revision when alerted by global RA team.
- Disseminate relevant information to team(s) as appropriate
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
- Provide centralized support for SPO maintenance, statistical analysis, reporting monthly and annually.
.
-
Sr. Associate Regulatory Affairs
2 weeks ago
مصر, Egypt Amgen Full time**Labeling and packaging activities management for Middle East North African region for Amgen portfolio** - Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region - Ensure delivery of right first time label source text for artwork creation - Ensure implementation of master artworks as...
-
Senior Regulatory Affairs Associate
6 days ago
مصر, Egypt Amgen Full timeCareer Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve...
-
Regulatory Affairs Head
4 hours ago
مصر, Egypt Antal International Full timeOne of the leading FMCGs companies is looking to hire a Regulatory Affairs Head! Key Responsibilities: - You will be managing Quality QPD, IMPD, and HSE - As Regulatory Affairs Head, your stakeholders will be EMPA, HACCAP, ISO and other Food related associations. - You will be responsible for labelling on both levels locally and globally. - Managing the...
-
Regulatory Affairs Specialist
4 hours ago
مصر, Egypt Alcon Full timeThe Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and...
-
Regulatory Affairs Associate, Gem
2 weeks ago
مصر, Egypt Acino Pharma Full time**Cairo, Egypt, Middle East, Turkey, and Africa**: Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and...
-
Director, Regulatory Affairs
2 weeks ago
مصر, Egypt اورنچ مصر Full timeAbout the job Director, Regulatory Affairs **Purpose of the job** Managing the regulatory affairs, overseeing the industry practices & ensure all government regulations being met to support the current and future strategic plans of Orange. **Duties and responsibilities** - Ensure coordination and enrichment of the company's strategic plan. - Provide...
-
Head of Regulatory Affairs
2 weeks ago
مصر, Egypt Johnson & Johnson Full time**Position **Summary**: **The Head of Regulatory Affairs JENA **will be responsible for leading regulatory affairs activities in the cluster for the Janssen portfolio and support the local GPH regulatory team (limited support) as required striving for convergence in ways of working. The JENA cluster comprises Egypt, Libya, Sudan, Ethiopia, and any new...
-
Senior Regulatory Affairs Specialist
2 weeks ago
مصر, Egypt Johnson & Johnson Full timeJohnson & Johnson Medtech is recruiting for a** Senior Regulatory Affairs Specialist** to** **be located in Cairo, Egypt. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and...
-
مصر, Egypt Kinetic Full timeA leading **Medical Device** company is actively recruiting a **Regulatory Affairs and Quality Assurance Specialist for** their **Egypt** office. **The main responsibilities will include but not limited to**: - Enhance and develop regulatory compliance of management system. - Define and execute regulatory plans and manage timelines to achieve the stated...
-
Regulatory Affairs Process
2 weeks ago
مصر, Egypt Johnson & Johnson Full time**Position Summary**: In this role, you will ensure that J&J's pharma products, processes, and operations comply with all relevant local, national, and international regulations and standards. You will work across the NEMA region which comprises the Near East, Maghreb, and African countries, meaning that your work will span across a whole continent, shaping...