Johnson & Johnson Medtech is recruiting for a Senior 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:
The main task of a Senior Regulatory Affairs Specialist is to provide regulatory support for the countries in the Gulf, Levant and Iraq region . You will partner with marketing, sales, operations, and other teams as well as manage regulatory submissions in compliance with local country requirements.
As a Senior Regulatory Affairs Specialist , you will:
- Forecast & plan annual submissions according to business priorities and in collaboration with marketing and commercial colleagues.
- Responsible for product lifecycle management of the portfolio under scope of responsibility by planning and coordinating requirements for compiling submission dossiers for all types of regulatory activities according to each country rules and regulations including new products registration, re-registration, listing, changes and custom clearance.
- Ensure timely submission, follow up and approval of submitted registration/market authorization applications through collaboration and communication with distributors in local markets ensuring timely launch of NPI’s and NPD’s and full regulatory compliance of registered products at all times, ensuring compliant business continuity.
- Effectively communicate and collaborate cross functions with internal stakeholders including sales and marketing teams to understand business priorities, support and provide regulatory documents to support tender requests, understand and communicate accurately regulatory requirements to global regulatory affairs teams.
- Build a strong relationship with external stakeholders including distributors in the countries by conducting follow up meetings to ensure continuous progress of opened applications and obtaining timely approvals, as needed provide training and knowledge on internal processes, products and common documentation.
- Conduct FSCA, FSN and complaints reporting activities according to each country’s regulations.
- When necessary, conduct copy review of marketing materials and submit for Health Authority approval in countries where it is applicable.
- Maintain all internal databases up to date as per internal SoP’s.
- Is able to anticipate and flag risks to relevant stakeholders, when necessary, along with providing proposed solutions and action plan.
A successful candidate for our position will need to have:
- Obtained University Degree in Medicine , Pharmacy, Biomedical Engineering or Sciences.
Experience and Skills:
- Proficiency in Arabic and English is a must.
- Minimum of 4 years of experience in a similar Regulatory Affairs position is a must.
- Previous experience in a Medical Devices Multinational Company required.
- Previous regional Regulatory experience is preferred.
- Strong personality with ability to define and change priorities and still manage tasks as business activity dictates.
- Strong organizational skills and ability to plan and manage own work agenda independently.
- Big picture orientation.
- Results and quality driven candidate with great problem-solving skills.
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 feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!