- Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- stays updated on relevant local regulations and guidelines and to develop and maintain positive relationship with key stakeholders in the regulatory environment.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Maintains a positive relationship with internal and external regulatory contacts.
- Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures.
- Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
- Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensures that files and archives related to Regulatory are kept updated and complete.
- Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
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Senior Regulatory Affairs Specialist
منذ أسبوع
IQVIA محافظة القاهرة, مصرJob Overview · Essential Functions · - Acts as a Regulatory Team Leader on more complex projects, which may include technical writing; · - Prepares and/or reviews regulatory documentation in area of expertise, as appropriate; · - Establishes relationships with many customers; may ...
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IQVIA محافظة القاهرة, مصرJob Overview · Essential Functions: · - Act as a Regional Regulatory Team Lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level in Middle east and north Africa region. · - Act as client' representative in fr ...
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Financial affairs specialist
منذ 5 أيام
مكتبة مصر العامة Cairo, مصرLeading multi-disciplinary team is looking for a Senior Civil Engineer to work on civil/sports field projects for their Akron team · Responsibilities: · Oversee/review designs/specifications for civil and sports field projects · Oversee/review construction plan preparation/permit ...
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Legal affairs specialist
منذ 5 أيام
مستشفى الأمل التخصصي Cairo, مصرOpen Position: Senior Software Developer, Magento (MNC Tech-based Company) · An MNC Tech-based Company is looking for Senior Software Developer to join the team and be based in the Selangor This is a new expansion team responsible for the software development, implementation and ...
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Administrative affairs specialist
منذ 5 أيام
مكتبة مصر العامة Cairo, مصرAn industry leading multi-disciplinary team is looking for a Traffic Engineer for their Cleveland, Ohio team · Responsibilities: · Work closely with Senior Project Engineers/Project Managers on design and roadway/highway improvement projects · Develop traffic improvement solution ...
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Top Business Cairo, Egypt Cairo, مصرLead the planning and delivery of the Internal Communications Strategy to build belief and understanding in our strategy, and drive priorities and business success. · Lead internal communications initiatives and campaigns that are aligned with local and broader goals and drive em ...
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Regulatory Affairs Specialist Name
منذ 6 أيام
Unilever Egypt Cairo, مصرResponsiblity: · Communicating with clients to understand their needs and explain product value. · Building relationships with clients based on trust and respect. · Collaborating with internal departments to facilitate client need fulfillment. · Collecting and analyzing data to l ...
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Regulatory Affairs Specialist Serving
منذ 6 أيام
AMICO Group egypt Cairo, مصرResponsibilities: · Interviewing executives, managers, and employees to determine compliance-related priorities. · Reviewing documentation, processes, and practices. · Developing and enacting regulatory compliance strategies. · Coordinating regulatory compliance procedures across ...
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Senior Regulatory Affairs Specialist
منذ أسبوع
Johnson & Johnson Egypt Cairo, مصرForecast & plan annual submissions according to business priorities and in collaboration with marketing and commercial colleagues. · Responsible for product lifecycle management of the portfolio under scope of responsibility by planning and coordinating requirements for compiling ...
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Johnson & Johnson Egypt Cairo, مصرA-Pricing Duties & Responsibilities · Strategic and operational pricing: · The senior pricing and tender Planning Specialist will work internally with different functions to support in setting the pricing strategy at level of list and net prices for Janssen in line brands and ne ...
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Trade and Employment Officer
منذ 4 أيام
International Labour Organization Cairo, مصر· Job Description · Description · –> · The target groups are government officials from ministries responsible for trade and investment, labour, economic affairs, planning, education, and other relevant line ministries; staff in national statistical agencies; representatives from ...
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Human Resources Specialist
منذ أسبوع
كويك كونكت Giza, مصرThe successful candidate for this position will be a 1099 contractor with Music Ministry International and be responsible for the following: · GENERAL: This is a non-personal service contract under which the personnel rendering the services are not subject, either by the contract ...
Regulatory Affairs Specialist - Cairo, مصر - Alcon
وصف
Regulatory Compliance