Description

Kenvue is currently recruiting for:

Regulatory Affairs Manager Nordics (m/f/d)

Location: Solna

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 within their geographical area of responsibility as well as requirements and strategies for regulatory submissions and approval pathways (where relevant) 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

• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local regulatory requirements.

• Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical 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 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 and product development

• 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

What's in it for you

• Competitive Total Rewards Package
• Paid Company Holidays, Paid Vacation, Flexible Ways of Working & 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.