Regulatory Affairs Specialist

3 days ago

القاهرة, Egypt Johnson & Johnson Full time

Company Description: (Business Overview)

Johnson & Johnson

We are recruiting for Regulatory Affairs Specialist 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.

Main performance measures (Performance Goals):

- Attending meeting with the MOH representatives to solve any pending issues.
- 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 th

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