Description

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\xc2\xae, AVEENO\xc2\xae, TYLENOL\xc2\xae, LISTERINE\xc2\xae, JOHNSON\'S\xc2\xae and BAND-AID\xc2\xae that you already know and love. Science is our passion; care is our talent. Our global team is made by 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

Manage Regulatory activities across AMET products for cosmetics & Personal care, medical devices, and pharmaceutical products to meet Business/Regulatory requirements

• Work autonomously, but in alignment with AMET Regulatory Director, to oversee day-to-day Regulatory Affairs activities for UAE, Gulf, Levant & Other Middle East Markets.
• Build and develop networks and strong working relationships with internal & external bodies, customers & other internal & externals stakeholders
• Good Regulatory Practice
• Regulatory Intelligence Lead for AMET, to Understands the regulatory landscape across the region, monitors the regulatory environment and provides support with impact assessments of new and changing regulations on the company\'s areas of interest
• Manage activities at a departmental level on both short- and long-term department and company objectives.
• Regulatory Intelligence: Understands the regulatory landscape across the Middle East and North Africa region. Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company\'s areas of interest as described in WWWSP-000328
• Manages compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are in place and adhered to.
• Manages strategies and oversee coordination, compilation and submission of regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements.
• Manage processes to develops, translates, reviews (where relevant) and approves artwork, where relevant, and promotional materials to ensure regulatory compliance for submissions.
• Monitors progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.
• Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
• Interacts with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters.
• May provide risk assessments on competitive claims balancing business needs and risks to be challenged by NGO\'S, authorities, or competitors.
• Provides assessments and data to execute plans to address sensitive issues.
• To be a proactive and credible business partner to Regulatory Affairs and in-market and/or Regional Business colleagues.
• To provide coaching, training, and support, as required.
• To manage 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.

Qualifications

What We Are Looking For

• Excellent Oral & written English communication skills
• Education: B.Sc. of Pharmaceutical Sciences (Life Science Degree or equivalent qualification with a major in pharmaceuticals)
• Years of Experience: 13 years

• Experience with a multi-national / regional company
• Experience in Pharma, Medicine and Cosmetics & Personal Care products
• In depth knowledge of MENAP and European legislation.

eQuest