Regulatory Affairs Labeling and Compliance

Janssen Egypt is recruiting for Regulatory Affairs Labeling and Compliance 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. 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. Summary of the job:**Participate and lead compliance initiatives**: gap analysis, quality investigations and remediation activitiesParticipate and lead process improvements initiativesPerform labeling and artwork activitiesSupport RA activities and projects as needed Duties & Responsibilities:**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.Participate and lead process improvements initiatives by reviewing current processes and assessing team's needsCreate new procedures to standardize the regulatory affairs activitiesMonitor 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 readinessCreate tools to monitor Compliance and maintain themUpdate local trackers and systems as neededParticipate in lifecycle management activities as needed**Qualifications**:Experience Required**Education**: bachelor degree in Pharmacy or equivalent**Years of Experience**: minimum 3 years of experience in Regulatory AffairsPrevious regulatory experience in pharma multinational**Location**: Cairo - Egypt**Language**: English, arabic Technical/Functional Skills RequiredMotivated and enthusiastic with positive mindsetPrecision and accuracy in task executionAssiduity and hard working**Microsoft tools proficiency**: Excel (+++), One note, Power point and wordLeadership Profile 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 teamsFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiencesThat is why we, in Egypt, are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong"!Primary LocationEgypt-Cairo-New Cairo- OrganizationJanssen Egypt (7804)Job FunctionRegulatory AffairsRequisition ID2206054802W