Regulatory Affairs Compliance Specialist - Cairo

؜ - ؜new القاهرة ؜ -

Job details

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

Job Summary

  • Advertiser: Johnson & Johnson
  • Announcement date: 01/07/2022
  • Type of employment: -
  • Experience level: -
  • Educational level: -
  • Job location: new القاهرة
  • Salary: -
  • Phone number:

    Show phone number

More jobs like this

new القاهرة
01/07/2022

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 i…

new القاهرة
30/06/2022

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 a…

Cairo
10/01/2023

## **Job Description** **Are You Ready to Make It Happen at Mondel ēz International? ** **Join our Mission to Lead the Future of Snacking. Make It With Pride.** You execute the scientific and regulatory affairs strategy for your respective category or categories and geographical area using your sc…

new القاهرة
03/02/2023

We, at Janssen Egypt, are 150+ passionate employees working tirelessly to make the world a better place and to treat, cure, stop, and prevent some of the most devastating and complex diseases of our time -- from immune-mediated diseases and cancers to mood disorders, pulmonary arterial hypertension…

new القاهرة
07/06/2023

### **Johnson & Johnson ** 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 John…

Cairo
05/10/2022

#### **Job Description** * Serve as regulatory representative to provide technical expertise, risk assessments, and solutions for product labeling, nutrition, and regulatory issues * Help prepare support documentation and regulatory submissions to NFSA and other authorities (Coordinate, prepare…

Cairo
18/01/2023

**Site Name:** Egypt - Cairo **Posted Date:** Jan 17 2023 ** Job Purpose:** * Evaluation, preparation, coordination &submission of regulatory documents in compliance with local regulations * Ensure regulatory compliance, timely submissions & secure regulatory approval in Gulf markets. *…

Cairo
20/03/2023

**:** * Preparation of license renewals and variation files according to current Ministry of Health requirements on all products for assigned countries * Do the submission compilation, publishing and approval information processes and tools. * Seeks opportunities and develops "rapport" with …

Cairo
18/10/2023

**Site Name:** Egypt - Cairo **Posted Date:** Oct 17 2023 ** Job Purpose:** * Responsible for timely delivery of regulatory activities of assigned Rx and/or Vx projects across dosage forms with minimal input from line manager. * Supports Global Regulatory by producing appropriate component…

new القاهرة
25/01/2023

We, at Janssen Egypt, are 150+ passionate employees working tirelessly to make the world a better place and to treat, cure, stop and prevent some of the most devastating and complex diseases of our time -- from immune-mediated diseases and cancers to mood disorders, pulmonary arterial hypertension,…

اللغة: العربيّة