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 care to touch the lives of over a billion people every day, throughout the world. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Sector/Organization Overview
Pharma /Regulatory affair
Summary of the job:
Regulatory Affair Associate Manager in GCC LOC (Bahrain, Kuwait, Saudi Arabia, Qatar, UAE, Oman & Yemen)
Duties & Responsibilities
• Prepare the Marketing Authorization Applications (MAA) and consequent regulatory processes for submission to Health Authorities, by national or centralized procedure for Janssen products in the GCC.
• Process Renewal for Janssen products & manufacturing sites registered in the GCC.
• Process CMC variations & Labeling up-date.
• Maintain an up-to-date database for all submissions in SPS, PKB, TrackWise, SharePoint.
• Ensure compliance with national legislation, international regulatory guidelines and internal requirements.
• Gathering regulatory intelligence
• Help shaping regulatory affair activities to the best practices Main performance measures (Performance Goals)
• Achievement level of set goals & objectives
• Quality & quantity of work output
Qualifications
Experience Required
• Education: Bachelor degree in Pharmaceutical Sciences
• Years of Experience: 3-6 years in Regulatory Affairs
• People management preferred
• Language: Arabic / English
• Location: Riyadh
Leadership Behaviors Required
• LIVE OUR CREDO: Demonstrate and inspire the behaviors that reinforce Our Credo.
• CONNECT: Develop deep insights into the needs of our patients, customers, markets and communities.
• SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally.
• LEAD: Create an environment where leadership and talent development is top priority.
• DELIVER: Deliver results by inspiring and mobilizing people and teams.
Technical/Functional Skills Required
• In depth knowledge of regulations/legislation -
• Strong in data gathering & interpretation
• Great communicator - Analytical, detail driven - Demonstrated ability to manage multiple assignments
• Constructive team player
Primary Location
Saudi Arabia-Ar Riyad-Riyadh-
Organization
Johnson & Johnson Middle East FZ-LLC Branch Legal Entity (8613)
Job Function
Regulatory Affairs
Requisition ID
2105967713W
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