Regulatory Affairs Associate
6 days ago
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Regulatory Affairs Associate
This position reports to the Regulatory Affairs Manager and is based at our office in Stockholm.
Due to the summer holiday season in Sweden, please expect a delay in the response on your application.
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 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 the 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 into 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 self-care treatments: Smoking Cessation, Digestive Health, and Cough & Cold.
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.
- 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 the Cluster Artwork Coordinator.
- Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
- Identifies & initiates local process improvement opportunities and manages changes as required.
- Assists in the preparation for internal and external audits and inspections in collaboration with others.
What we are looking for
Required Qualifications
- Relevant Bachelor's Degree or higher.
- 2+ years related regulatory experience.
- Knowledge of consumer healthcare environment and product development.
- Understanding of processes and departments within a healthcare company.
- Effective time and organization 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
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