Regulatory Affairs Specialist

Regulatory Affairs Specialist

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

Senior Regulatory Affairs Manager

Lieu :

Europe/Middle East/Africa, Turkey, Istanbul, Istanbul

Lieu de travail :

Hybride

Ce que tu vas faire

Kenvue is currently recruiting for:

Regulatory Affairs Specialist

This position reports into Senior Manager Regulatory Affairs and is based at Istanbul, Turkey

What we do

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®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who we are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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

Key Responsibilities

• Ensures compliance with regulatory agency regulations such as medicines, medical device, cosmetic, Food supplement, general products ( some of them) and interpretations.
• Assists in the coordination, compilation & submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility
• Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible. 
• Prioritizes, plans and monitors allocated projects against defined timelines
• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
• Prepares responses to regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
• Ensures that all assigned products comply with local regulatory and quality system requirements.
• Reviews and approves promotional materials for assigned to local products.

What we are looking for

Required Qualifications

• Relevant Bachelor's Degree (B. Pharm) or higher (M. Pharm, MSc. Pharm etc.)
• 6+yrs related regulatory experience. 
• Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility
• Broad knowledge of consumer healthcare environment and product development
• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational and time management skills with an ability to work under pressure.
• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic,
• Results-driven environment.
• Able to work effectively in a multi-cultural, highly matrixed organization
• Proficiency in English

What’s in it for you

• Competitive Package
• Learning & Development Opportunities
• Kenvuer Impact Networks

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit 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.

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