Regional Regulatory Strategist

**JOB INFORMATION** **JOB SUMMARY** Summarize the primary purpose & key accountabilities of the job. - Handle related regulatory strategies for allocated Products, and ensure communication/clarity of regulatory timelines and strategy. - Single point of contact for global/product strategists, and In-Country Regulatory Team on regional issues to facilitate the...

Job Description: - Coordinate & manage post approval submissions including Marketing Authorization Transfer (MAT) for the group of assigned markets - Develop & manage post approval including MAT plan, strategy, timelines and execution in alignment and partnering with key stakeholders (i.e. PGS, Markets, Clusters, Labeling team, Submissions Management, CMC,...

**The Big Picture**: DigiSay is the biggest MCN (Multi-Channel Network) in Egypt and the 3rd largest in the Middle East. Right now we are transforming ourselves into a digital media company (including: production, marketing and distribution of digital media). Our overall objective is to become the biggest digital media company in the EMEA region. We are a...

**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...

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: -...

Johnson & Johnson Medical is recruiting for **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 well-being of people....

**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 empathy and...

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 empathy and provide an environment that supports...

**Position Summary** Accountable for the achievement of the local affiliate, Cluster and Corporate objectives, in collaboration with the affiliate RA Manager to support in RA Egypt affiliate and Levant region, and provide Regulatory Affairs support to the local affiliate to help the market(s) achieve their revenue and growth targets: - Obtain new product...

**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...

**JOB CONTEXT** The Regulatory Specialist reports hierarchically into the Regulatory Manager and may have a regional or global scope. **KEY ACCOUNTABILITIES** **Regulatory and Compliance Management** Investigate all kinds of incidents and reports and provide expert advice to more senior colleagues. Minimize risk exposures and ensure adherence with...

**Description** **Regulatory Consultant** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

Career 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...

**Johnson & Johnson**: 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 well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health...

**Job Summary**: - Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting. - Labeling and packaging activities management for Middle East North African region for Amgen portfolio **Key Activities**: - Systems Management to deliver both strategic...

**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...

Company Profile: At Unilever you are more than your job title, you are part of the world’s most successful, purpose-led business. Work with brands that are well-loved around the world, that improve the lives of our consumers and the communities around us. We produce world-leading brands including Lipton, Knorr, Dove, Axe, Hellmann’s and Omo, alongside...

Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify...

**MultiCare **Egypt for Pharmaceutical Industries is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, gender identity or expression, age disability, or other characteristics protected by prevailing regulations, practice or customs/traditions. **MultiCare** is a...

**Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. The role will have focus on Line Manager duties and people management. **Essential Functions** - Oversee...