Senior Regulatory Affairs Associate

1 day ago

مصر, Egypt Johnson & Johnson Full time

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.

**Key Responsibilities**:

- 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**:
**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.

  • Senior Regulatory Affairs Associate

    1 week ago

    مصر, Egypt Amgen Full time

    Career Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve...

  • Regulatory Affairs Head

    3 days ago

    مصر, Egypt Antal International Full time

    One of the leading FMCGs companies is looking to hire a Regulatory Affairs Head! Key Responsibilities: - You will be managing Quality QPD, IMPD, and HSE - As Regulatory Affairs Head, your stakeholders will be EMPA, HACCAP, ISO and other Food related associations. - You will be responsible for labelling on both levels locally and globally. - Managing the...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    مصر, Egypt Johnson & Johnson Full time

    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...

  • Regulatory Affairs Specialist

    3 days ago

    مصر, Egypt Alcon Full time

    The Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and...

  • Regulatory Affairs Associate, Gem

    2 weeks ago

    مصر, Egypt Acino Pharma Full time

    **Cairo, Egypt, Middle East, Turkey, and Africa**: Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and...

  • Associate Regulatory Affairs Mea

    1 week ago

    مصر, Egypt Amgen Full time

    Career Category Regulatory **Job Description**: Job Summary: - Labeling and packaging activities management for Middle East North African region for Amgen portfolio - Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting. Key Activities: -...

  • Regulatory Affairs Specialist

    1 day ago

    مصر, Egypt Target Recruitment & HR Solutions Full time

    **Job Requirements**: - Pharmaceutical/Science Bachelor’s Degree or any related field. - 1-2 years experience in Regulatory Affairs, preferably with an FMCG/ pharmaceutical company - cosmetics an asset. - Local knowledge of some MENA regulations for cosmetics, medical devices, or pharmaceutical products. - Fluent in French. - Strong verbal and written...

  • Develop Within Regulatory Affairs, Ra Specialist

    2 weeks ago

    مصر, Egypt NonStop Consulting Full time

    This role would be a great chance to start your career within Regulatory Affairs department or continue your development and improve your experience and skills to become a successful Regulatory Affairs professional working for a world leader in Medical Devices field. Regulatory Affairs is a very sought after field and you will be able to learn lots and use...

  • Regulatory Affairs Supervisor, Egypt

    1 day ago

    مصر, Egypt AstraZeneca Full time

    The job holder will be responsible for performing activities in drug regulatory affairs, he/ she will: **Core Accountabilities** **Regulatory**: - Ensure timely, accurate and compliant labelling translations and artwork preparation for assigned products - Recommend changes for labelling, manufacturing, and marketing for regulatory compliance - Monitor and...

  • Regulatory Affairs Specialist

    7 days ago

    مصر, Egypt Medtronic Full time

    **Careers that Change Lives** We are a company who inspiring the extraordinary, for more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives. The role is opened to continue our daily milestone in serving our patients & partners and give them the highest...