Regulatory Affairs Group
Regulatory Affairs Specialist Egypt and Africa
Job title Regulatory Affairs Specialist Egypt and Africa Function Regulatory Affairs Group Sub function Regulatory Product Submissions and Registration Category Analyst, Regulatory Product Submissions and Registration (P4 - E24) Location Cairo, Egypt Date posted Feb 16 2025 Requisition number 2506238966W Share
Description
Johnson & Johnson
We are recruiting for Regulatory Affairs Specialist-Egypt and Africa based in Cairo, for Egypt and other markets.
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 Regulatory Affairs Specialist in Johnson & Johnson is to Develops skill set to enable value added individual contributions, who works under close supervision. Applies methods for planning, directing, coordinating and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/ government standards.
Duties & Responsibilities:
Assists by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed meet regulatory agency requirements.
Applies functional analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market.
Contributes on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets.
Advises product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process.
Carries out the detailed regulatory submissions required for new and existing product approvals and registrations.
Coordinates Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits.
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
This job is salaried.
Main performance measures (Performance Goals):
Attending meeting with the MOH representatives to solve any pending issues. Compiling products technical information requested for registration from different online International Registration Request Tools. And communicate with international regulatory affiliates through e-mails Preparation of registration, re-registration and Variation files for all franchises and business units. Fulfilling MOH requirements for submitted files. Check the expiry date of all certificates and request the renewed one for any nearly expired certificate every quarter and follow up with the international regulatory affiliates until obtaining the renewed certificate. Preparation of all required original certificate and registration license requested for the distributors or sales for tenders.
Qualifications
Experience Required
Education: a bachelor's degree in a life-sciences-related field like pharmacy, Science, or Veterinary Medicine Experience: 3-4 Years of experience in Regulator affairs working in multinational Medical Devices company Having an experience in dealing with Healthcare Authorities Language: Arabic, English. Location: Cairo, Egypt Relocation availability: No
Leadership Behaviors Required
LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and Ensures everyday actions contribute to Our Purpose CONNECT: Builds internal and external relationships based on respect, Collaborates openly across boundaries and acts as a team player. SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change. Grow: Develops self and others to reach their goals, engages in open & honest conversations and Drives performance by managing energy and taking ownership for outcomes.
Technical/Functional Skills Required
Collaboration and Teaming Negotiation skills High sense of urgency Communication Skills Presentation Skills Time Management Skills of working under pressure
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 JNJ 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”!
- 基本信息：姓名、生日、民族、性别、国籍、照片；
Basic Information: Name, Birthday, Ethnicity, Gender, Nationality, Headshot;
- 联系信息：住址、电话号码、电子邮件地址；
Contact Information: Address, Phone Number, Email;
- 教育工作信息：职业、职位、工作单位、工作经验、教育背景、学历、学位、培训记录。
Academic & Professional Information: Occupation, Position, Employer, Work Experience, Educational Background, Degree, Training Records.
鉴于强生全球集团业务的全球化经营性质，当您向强生中国应聘职位时，强生中国会按照《应聘者隐私政策》所述情形，向境外接收方及其经授权的第三方提供您的个人信息，包括但不限于：
Due to the global nature of the operation of Johnson & Johnson Family of Companies, in the course of processing your application with J&J China, J&J China may provide your personal information to the overseas recipient and authorized third parties in accordance with J&J’s Careers Privacy Policy, including but not limited to:
除强生中国或法律特别要求外，请您避免在您的申请中提交可能会被视为敏感个人信息的信息，即生物识别、宗教信仰、特定身份、医疗健康、金融账户、行踪轨迹，以及不满十四周岁未成年人的信息等一旦遭遇泄露或非法使用，容易导致人格尊严受到侵害或者人身、财产安全受到危害的个人信息。
Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual’s personal dignity or harm to personal or property safety.
前述境外接收方为：美国强生公司（Johnson & Johnson Services, Inc.），其联系方式为：美国新泽西州新不伦瑞克市强生广场一号。
The overseas recipient is Johnson & Johnson Services, Inc., which can be contacted at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, U.S.
境外接收方将按照如下目的和方式处理您的个人信息。
The overseas recipient will process your personal information in accordance with the following purpose and method:
处理目的：根据强生全球集团“统一人力资源（One HR）”原则，对人才招募进行全球统一管理，具体请参见《应聘者隐私政策》中“我们收集此类个人信息的原因”部分。
Processing
