Manager Regulatory Affairs Nordics

Manager Regulatory Affairs Nordics

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Sr Regulatory Affairs Manager Nordics

Locatie:

Europe/Middle East/Africa, Sweden, Stockholm, Solna

Werklocatie:

Hybride

Wat je gaat doen

Kenvue is currently recruiting for:

Regulatory Affairs Manager Nordics (m/f/d)

This position reports to Senior Regulatory Affairs Manager Nordics based at Solna, Sweden.

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 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.

The Regulatory Affairs Manager, Cosmetics is a country expert with an in-depth understanding of the regulatory environment and requirements within their geographical area of responsibility along with compliance activities and to assess and communicate the potential impact of these on business objectives.

Responsibilities:                    

Regulatory Strategy

·        Provides regulatory input and technical guidance on local regulatory requirements to product development teams

·        Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided data are consistent with the local regulatory requirements and support the proposed product claims.

·        Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.

Regulatory Compliance

·        Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally

·        Ensures that all products comply with local regulatory and quality system requirements.

·        Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions

·        Reviews and approves promotional materials for all local Kenvue products and assists in claim support along with the Cluster.

·        Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.

·        Ensures that the enterprise Regulatory systems are accurate and fully maintained

·        Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally

·        Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives

·        Manages and supports internal and external audits and inspections in collaboration with quality function

Qualifications

·        Relevant Bachelor's Degree or higher 

·        8+yrs related regulatory experience 

·        Deep expertise across EU/ Nordics Cosmetics regulatory requirements is essential, with additional experience of Commodities and/or Medical Devices preferred

·        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 cosmetic regulation as a minimum within their geographic area of responsibility

·        Broad knowledge of consumer healthcare environment

·        Able to work effectively in a multi-cultural, highly matrixed organization

·        Experience in cultivating and leveraging strategic networks and partnerships

·        Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic, results-driven environment.

·        Ability to represent Regulatory Affairs function on cross-functional teams and governance forums

·        Proficiency in English

·        Fluency in Swedish, Norwegian or Danish

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 identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Als u een persoon met een handicap bent, kijk dan op onze pagina Hulp bij handicap voor informatie over het aanvragen van een accommodatie.