Johnson & Johnson Careers

Senior RA Associate

Cairo, Egypt
Regulatory Affairs


Job Description

Requisition ID: 1905736328W

Johnson & Johnson

Johnson & Johnson Egypt is recruiting for a Senior Regulatory Affairs Associate to be located in Cairo.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 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.

Sector Overview

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com

Main objectives

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

Key tasks and responsibilities

Submit products 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.

Be involved in all aspects of the application to take the product to market.

Execute regulatory plans and manage timelines to achieve the stated goals.

Ensure that relevant local regulations are properly communicated to the different stakeholders 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 guidance documents.

Provide regulatory support to all company functions upon request.

Comply 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 relevant laws & regulations as well as J&J guidelines.

Relationships

Directly reports to: Senior Regulatory Affairs Manager

Functional relationships with: Internal:

All

External:

Local Health Authorities


Qualifications

Education & Qualifications

Bachelor's Degree from Medical related field.

5 years of experience in Regulatory Affairs field.

Minimum 2 years in a multinational company.

Knowledge & Abilities

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.

Skills

  • Confident communication and presentation skills, both verbal and written.
  • Demonstrated ability to manage multiple assignments.
  • Strong interpersonal skills to deal with sensitive and occasionally contentious issues.

Personal Qualities

  • Ability to work cross -functional to resolve complex issues.
  • Desire to work as part of an effective, cohesive group.
  • Highly organized.

 


Primary Location
Egypt-Cairo-Cairo-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Regulatory Affairs
Requisition ID
1905736328W