Johnson & Johnson Careers

Regulatory Affairs Associate

Cairo, Egypt
Regulatory Affairs

Job Description

Requisition ID: 1805630961W

Main objectives

  • Registration of new products and/or presentations and renewal of existing ones
  • Maintenance of established products.
  • Liaising between the LOCs & the global teams (Labeling, Quality, CMC, etc).
  • Update & maintenance of regulatory databases & systems.
  • Align with J&J guidelines and local laws & regulations.

Task & Responsibilities 
  • Submit products files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives.
  • Handle the preparation, review, submission and follow-up of regulatory files in the proper format and in compliance with local regulations.
  • You should be involved in all aspects of the application to take the product to market.
  • Execute regulatory plans and handle timelines to achieve the stated goals.
  • Ensure that important local regulations are properly communicated to the different partners internally & externally.
  • Respond to inquiries from the different HAs.
  • Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities.
  • Update regulatory databases, tracking tables & information systems.
  • Develop & maintain relationships with Health Authorities & other relevant organizations.
  • Maintain current knowledge of existing as well as emerging regulations, standards and guiding documents.
  • Provide regulatory support to all company functions upon request.
  • Align with local laws & HCC guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC).
  • Ensure that all regulatory activities are conducted in compliance with significant laws & regulations as well as J&J guidelines.
Interpersonal Skills
  • Confident communication and presentation skills, both verbal and written.
  • Shown ability to handle multiple assignments.
  • Strong interpersonal skills to take care of sensitive and occasionally contentious issues.
  • Ability to work cross -functional to resolve complex issues.
  • Dream to work as part of an effective, cohesive group.
  • Highly organized.

Directly reports to: Senior Regulatory Affairs Manager

Functional relationships Internally: All

External: Local Health Authorities


Bachelor's Degree from Medical related field.

Past experience in RA field.

Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines.

Strong knowledge base and skill set in science.

Excellent relationships with MOH Officials within Health Authorities & other relevant organizations.

Primary Location
Janssen Pharmaceutica N.V. (7555)
Job Function
Regulatory Affairs
Requisition ID