Regulatory Affairs Associate - 2407022634W

Description

Kenvue is currently recruiting for:

Regulatory Affairs Associate

This position reports to the Regulatory Affairs Manager and is based at our office in Solna, Stockholm.

Due to the summer holiday season in Sweden, please expect a delay in the response on your application.

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 Regulatory Affairs Associate is responsible for overseeing a range of regulatory activities for their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.

Key Responsibilities

Regulatory Strategy

• 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 organizes 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.

• Prioritizes, plans and monitors allocated projects against defined timelines.

• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.

Regulatory Compliance

• Assists in the maintenance of compliance for all products with local regulations and quality system requirements.

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

• Reviews and approves promotional materials for assigned local Kenvue products.

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

• Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.

• Identifies & initiates local process improvement opportunities and manage changes as required.

• Assists in the preparation for internal and external audits and inspections in collaboration with others.

Qualifications

What we are looking for

Required Qualifications

• Relevant Bachelor’s Degree or higher.

• 2 yrs related regulatory experience.

• Knowledge of consumer healthcare environment and product development.

• Understanding of processes and departments within a healthcare company.

• Effective time and organisation management.

• Full proficiency in both Swedish & English.

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-Sweden-Stockholm-Solna

Job Function Regulatory Affairs

Req ID: 2407022634W