Senior Regulatory Affairs Associate - Egypt

A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide.

"By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives."

Johnson & Johnson Innovative Medicine Egypt is recruiting for a Regulatory Affairs Specialist, located in Cairo. This position will work in a hybrid home/office model.

The JENA cluster comprises Egypt, Jordan, Libya, Sudan, Ethiopia, and any new business within the geographical scope.

The role is ultimately accountable for the local Regulatory Affairs team activities in the JENA cluster including filing strategy and compliance.

Empower the organization to foster collaborative thinking to further drive regulatory innovation and catch the right opportunities to shape the regulatory environment across JENA, applying GRA standard processes.

Key Responsibilities

• Be involved in all aspects of the application to take the product to market.
• Submit product files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives.
• Coordinate the preparation, review, submission, and follow-up of regulatory files that are properly formatted and in compliance with local regulations.
• Implement regulatory plans and manage timelines to achieve the stated goals.
• Ensure that relevant local regulations are properly communicated to the different collaborators internally & externally.
• Respond to inquiries from the different HAs.
• Communication & Negotiation with the Ministry of Health to overcome any obstacles that may affect the product availability.
• Develop & maintain relationships with Health Authorities & other relevant organizations.
• Maintain current knowledge of existing as well as emerging regulations, standards, and guidance documents.
• Provide regulatory support to all company functions upon request.
• Follow local laws & HCC guidelines, the Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
• Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines.
• Contribute in the development of Egyptian regulatory decrees & guidelines by active participation in the pharmaceutical industry & MOH meetings.
  
  

Qualifications

Education

• University degree or equivalent experience in the life sciences field or a related field.
  
  

Experience and Skills:

• Bachelor's Degree in Pharmaceutical Science
• At least 5-6 years of experience in Regulatory Affairs.
• Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines.
• Experience in the use of a selection of the following technologies: Information systems based on database technology or Web/Internet technology, document management systems
• Fluent in spoken and written English and Arabic
• Ability to manage multiple assignments
• Ability to work in a matrix environment
• Organizational skills
• Good communication and presentation skills, both verbal and written
• Results and Performance Driven
• Analytical Thinking
• Flexibility/Adaptability
  
  

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against based on disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.