Regulatory Affairs Associate Manager

**Description**:
Johnson & Johnson Consumer Saudi Arabia Limited, is recruiting for a Regulatory Affairs Associate Manager to be located in Riyadh, Saudi Arabia.

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

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. There are more than 265 Johnson & Johnson operating companies employing approximately 126,500 people and with products touching the lives of over a billion people every day, throughout the world.

Growing 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/Organization Overview**:
Regulatory Affairs, Johnson & Johnson Consumer Health

**Summary of the job**:

- Execute Regulatory activities across products, cosmetics, Consumer Healthcare, and medical devices to meet Business/Regulatory requirements for the Johnson & Johnson Consumer Family of Companies.

**Duties & Responsibilities**:
Work autonomously, but in alignment with local manager, to coordinate day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
- Handle activities at a departmental level on both short
- and long-term department and company objectives.
- Works autonomously in Agility squad forms maintaining agility concepts for Customer / Consumer Obsession, empowerment, Cross-Functional collaboration, Bold prioritization and Test & Learn methodology.
- Understands the regulatory landscape in Saudi Arabia in general and SFDA specifically. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company's areas of interest.
- Handles compliance within the department by ensuring global, regional, and local processes, policies, Sops and working instructions are in place and adhered to.
- Handles the coordination, compilation and submission of regulatory submissions, responses to regulatory agency’s questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements as per our Regulatory Standard Management SOPs.
- Develops, translates, reviews (where relevant) and approves Labeling, artwork, where relevant, and promotional materials to ensure regulatory compliance for submissions.
- Leads, monitors, assesses and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management
- Integrates and executes results-oriented Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.
- To handle external contractors and consultants to ensure that appropriate standards and timelines are met.
- Works with strategic direction and performs with a high degree of independent judgment and execution which directly impacts the operational results of the business unit.
- Management of admin support for e-Market Place Purchasing controls.
- Follow Good Documentation and Data Integrity Practices in accordance with cGMP in J&J systems as CEDMS, RegPoint..etc.

**Good** **Regulatory** **Practice**:

- To ensure the maintenance of accurate records (archives) of regulatory activities and registrations documentation, as appropriate.
- Assists in the development of standard methodologies for Regulatory Affairs processes.
- To develop networks and strong working relationships with regulatory agency and industry bodies.
- Build and maintain excellent relationships with relevant regulatory bodies, external bodies, contractors and corporate partners which will have direct impact on Regulatory function.

Build and develop networks and strong working relationships with internal customers:

- To provide general regulatory advice.
- To provide regular updates, reports & Metrics.
- To specifically develop strong working relationships with Regional & Global RA, Regulatory contacts and LOC business stakeholders

**Qualifications**

**Qualifications**:
**Experience Required**:

- Education: Life Science Degree or equivalent qualification with a major in pharmaceuticals
- Years of Experience: 4 +Years Pharmaceutical/Regulatory Experience