Regulatory Affairs Manager
1 month ago
Description
recruiting for:
**Regulatory Affairs Manager**
This position reports into Head of Regulatory Affairs Middle East and is based at Riyadh, KSA.
**Who We Are**
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you Join us in shaping our future-and yours.
**What You Will Do**
The Regulatory Affairs Manager is responsible for execution of Regulatory activities across products, cosmetics, Consumer Healthcare, and medical devices to meet Business/Regulatory requirements for Kenvue.
Key Responsibilities***
- 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.
**Qualifications**:
**What We Are Looking For**
Required Qualifications
- Education: Life Science Degree or equivalent qualification with a major in pharmaceuticals
- Years of Experience: 6 Years Pharmaceutical/Regulatory Experience
- Language: Arabic/English
- Location: Riyadh - Saudi Arabia
Desired Qualifications
- Experience from a multi-national or regional company is required
- Experience in Pharma Medicine and Cosmetics & Personal Care products
- In depth knowledge SFDA’s regulation.
- Excellent Oral & written communication skills, in English and Arabic.
- Should have strong analytical problem solving and interpersonal skills, leadership, influencing, and presentation skills.
- Ability to work under pressure achieving consistently high results through individual and team efforts.
- Build and develop networks and strong working relationships with internal & external customers
**What’s In It For You**
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
- Learning & Development Opportunities
- Employee Resource Groups
Kenvue is proud to be an 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 on the basis of disability.
Primary Location Europe/Middle East/Africa-Saudi Arabia-Ar Riyad-Riyadh
Job Function Regulatory Affairs
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