Regulatory Affairs Manager

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.

For more information, click here .

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.

• 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 prioritie...