At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Cairo, Egypt
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for an RA Professional, Labeling to be in Cairo, Egypt.
Perform labeling and artwork activities: create and update labeling documents, annotate artworks, perform proofreading, coordinate labeling submission and implementation, follow-up on approvals and implementation internally with all involved functions, coordinate with supply chain the updated PILs implementation.
Execute artwork activities in relevant system including proofreading.
Manage and Coordinate Local Language translation of PIL/Labels.
Manage, Track and Maintain approved labeling materials archive and database.
Ensuring tracking of regulatory activities in global regulatory tracking tools in accordance with related SOPs.
Participate and lead process improvements initiatives by reviewing current processes and assessing team’s needs.
Support creating new procedures to standardize the regulatory affairs activities.
Act as subject matter expert for labeling related activities and procedures and perform regular trainings as needed.
Monitor RA activities from compliance perspective by sending newsletters, setting KPIs, ...
Support RA activities and projects as needed
Coordinate RA labeling & compliance projects with RA team and other functions as needed.
Update local trackers and systems as needed.
Participate in lifecycle management activities as needed.
Communicate and engage with Health Authority and address regulatory topics.
Perform related duties as assigned by supervisor.
Maintain compliance with all company policies and procedures.
Minimum Qualification
Minimally basic degree in Pharmacy.
2 years’ experience in Regulatory Affairs within a multinational organization, preferably Labeling experience
Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
Excellent computer proficiency including Microsoft applications.
Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
Required Skills:
Preferred Skills:
