Johnson & Johnson Careers
Regulatory Affairs Manager
Requisition ID: 1805694482W
Johnson & Johnson is recruiting for a Regulatory Affairs Manager to be located in Dubai, United Arab Emirates.
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.
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 & insert leaflet variations received from Global Regulatory Affairs (GRA).
- Maintain an up-to-date database for all submissions in SPS, PKB, TrackWise, SharePoint.
- Guarantee the compliance with national legislation, international regulatory guidelines and internal requirements.
- Bachelor degree in Pharmaceutical Sciences is required
- 7+ years of experience in a Regulatory Affairs role within the pharmaceutical industry
- Arabic fluency is a requirement for this role
- Confident communication skills, both verbal and written.
- Demonstrated ability to manage multiple assignments.
- Strong interpersonal skills to deal with sensitive and occasionally contentious issues.
- Problem solving
- Team collaboration working
United Arab Emirates-Dubai-Dubai-
Johnson & Johnson Middle East FZ-LLC (8608)