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Senior Regulatory Affairs Specialist - 2407022081W

Description

Kenvue is currently recruiting for:

Senior Regulatory Affairs Specialist

This position reports to Regulatory Northern Cluster & EMEA Self Care and is based at our Søborg office.

Who we are

At Kenvue (http://kenvue.com/careers) , 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 OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands like NEUTROGENA®, LISTERINE®, NATUSAN®, PIZ BUIN® and o.b. ®. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.

The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R & D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough & Cold. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M)

What you will do

The Senior Regulatory Affairs Specialist is responsible for ensuring the success of new product registrations, line extensions and new indications and claims in alignment with the business plan. They will also manage 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, as well as maintaining compliance for all products with local regulations and quality system requirements.

Key Responsibilities

Regulatory Strategy

• Works independently to provide 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 Health Authority requirements, where relevant.

• 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 classification and claims.

• 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.

• 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 assigned local Kenvue products and assists in claim support

• 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

• Supports internal and external audits and inspections in collaboration with quality function

Qualifications

What we are looking for

Required Qualifications

• Relevant Bachelor's Degree or higher

• 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

• Full proficiency in English

• Full proficiency in Danish

What’s in it for you

• Competitive Total Rewards Package

• Paid Company Holidays, Paid Vacation, Volunteer Time & More!

• Learning & Development Opportunities

• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Denmark-Hovedstaden-Birkerod

Job Function Regulatory Affairs

Req ID: 2407022081W