Regulatory Affairs Specialist

Janssen Egypt is recruiting for Regulatory Affairs 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 in dossier preparation and regulatory operational activities. Support labeling and CMC variations. Maintain an up-to-date database for all submissions. Keep control and follow-up of the files during Authorities evaluation, to optimize the approval timelines. Support regulatory quality and compliance activities. Duties & Responsibilities Participate in regulatory dossiers preparation for submission of new marketing authorization applications, renewals, variations and withdrawals Support database, trackers and system update Support labeling activities: proofreading, annotations, and archiving Support eCTD conversion project Support compliance projects and initiatives Guarantee the compliance with national legislation, international regulatory guidelines and internal requirements. To perform any other duties as requested by the management. Good alignment with local and global stakeholders with regards to submissions. Qualifications Experience Required Education: bachelor degree in science field Years of Experience: 2-5 years Experience: Previous regulatory experience in pharma multinational Language: English/Arabic Location: Cairo – Egypt Relocation availability: N/A Technical/Functional Skills Required Motivated and enthusiastic with positive mindset Precision and accuracy in task execution Assiduity and hard working. Microsoft tools proficiency: Excel (+++), One note, Power point and word Leadership Behaviors Required LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose CONNECT: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player. SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change. Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes. For 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 experiences That 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 Location Egypt-Cairo-New Cairo- Organization Janssen Egypt (7804) Job Function Regulatory Affairs Requisition ID 2206054643W