Regulatory Affairs Compliance Specialist - Cairo

Janssen Egypt is recruiting for Regulatory Affairs 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:
* Lead eCTD baseline conversions for assigned products
* Perform track and trace reporting for countries in scope and support track and trace project
* Participate in dossier preparation and regulatory operational activities
* Support labeling activities
* Support regulatory quality and compliance activities

Duties & Responsibilities:

• Coordinate eCTD baseline project with global team, local RA experts and distributors,


• Prepare eCTD conversion files for submission to the Has and follow-up on approval


• Perform track and trace reporting of master data to HAs for countries in scope and support track and trace project


• 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 compliance projects and initiatives

Qualifications

Experience Required

• Education: bachelor degree in Pharmacy or equivalent


• Years of Experience: minimum ‎3 years of experience in Regulatory Affairs is a must


• Previous regulatory experience in pharma multinational is a must


• Location: Cairo - Egypt


• Language: English, arabic

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 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 teams
  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
2206054793W