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.

• 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.

• 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.

• Monitors and progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.

• Leads, monitors, assesses and communicates risks on key projects, providing regular updates to Stakeholders and Senior Management

• Interacts with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters.

• Integrates and executes results-oriented Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.

• Management of admin support for e-Market Place Purchasing controls.

• Follow Good Documentation and Data Integrity Practices in accordance with c GMP in J&J systems as CEDMS , Reg Point ..etc.

Qualifications
What We Are Looking For

• 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

• 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