Senior Regulatory Affairs Specialist

7 days ago

Gladsaxe, Gladsaxe Municipality, Denmark Kenvue Full time

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.

Job Description - Senior Regulatory Affairs Specialist (2507030367W)

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 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 Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims, all while supporting business objectives. They manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products, ensuring a smooth approval process with regulatory agencies.

Beyond submissions, they play a crucial role in maintaining compliance with local regulations and quality system standards, ensuring all products meet the necessary legal and industry requirements.

Key Responsibilities

Regulatory Strategy

  1. Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams.
  2. Assesses the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
  3. 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.
  4. Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
  5. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
  6. Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional levels.

Regulatory Compliance

  1. 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.
  2. Ensures that all products comply with local regulatory and quality system requirements.
  3. Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs, and working instructions.
  4. Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support.
  5. Initiates, reviews, and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator.
  6. Ensures that the enterprise Regulatory systems are accurate and fully maintained.
  7. Ensures any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  8. Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
  9. Supports internal and external audits and inspections in collaboration with the quality function.

What we are looking for

Required Qualifications

  1. Relevant Bachelor's Degree or higher.
  2. 6+ years related regulatory experience.
  3. Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities, and/or Medical Devices.
  4. Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  5. Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  6. Fluent proficiency in Danish & English.

What's in it for you

  1. Competitive Total Rewards Package.
  2. Paid Company Holidays, Paid Vacation, Volunteer Time & More
  3. 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.

Background checks in the recruitment process

As a final candidate in our recruitment process, you may be subject to a background check. This process is important for us to ensure the quality of our recruitment process.

As part of this, it is important that we encourage you to make sure that the information in your CV is correct before submitting your application to us.

To carry out these background checks, we use a background check company. Different checks may be carried depending on the position that you are applying for. This could be, for example:

  1. Reference checks.
  2. CV-validation.
  3. Litigation checks, including criminal cases.

The background check company is an independent data controller for any personal data that they will process during the check.

Primary Location

Kenvue is an Affirmative Action and 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.

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