Description
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 GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Cairo, Cairo, EgyptJob 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
In this role, you will,
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 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.
Create new procedures to standardize the regulatory affairs activities.
Act as subject matter expert for labeling related activities and procedures and perform regular training needed.
Monitor RA activities from compliance perspective by sending newsletters, setting KPIs, ...
Support RA activities and projects as needed such as track & trace, RFT, archiving, eCTD baseline, ...
Coordinate RA labeling & compliance projects with RA team and other functions as needed.
Support the compliance initiatives: gap analysis and quality investigation and set remediation activities, change controls and audit readiness.
Create tools to monitor Compliance and maintain them.
Update local trackers and systems as needed.
Participate in lifecycle management activities as needed.
Support RA activities and projects as needed.
Communicate and engage with Health Authority and address regulatory topics.
Maintain compliance with all company policies and procedures
Experience and Skills:
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 the ability to effectively communicate with internal and external customers.
Excellent computer proficiency including Microsoft applications.
Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.
Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
