Regulatory Affairs Senior Specialist

Mcneil Ab; United States; Hybrid; USD 85,000 - 100,000; Full time

Job summary

Kenvue is seeking a Senior Regulatory Affairs Specialist to manage regulatory submissions and compliance across assigned regions. The role requires deep knowledge of regulatory frameworks for medicines, cosmetics, devices, or related products and strong collaboration with product development teams.

Location is Hybrid across Europe/Middle East/Africa region, with focus on Ukraine. English and Ukrainian proficiency are essential. Reports to the Head of Regulatory Affairs, CEE/R&D Site Lead Warsaw.

Qualifications

• Broad regulatory knowledge across drug, cosmetics, commodities, and/or medical devices.
• Proficiency in English and Ukrainian.
• Strong understanding of local regulatory requirements and submission processes.

Responsibilities

• Provide regulatory input and guidance to product development teams.
• Prepare and submit regulatory submissions per local requirements.
• Monitor regulatory review processes and maintain compliance with quality systems.

Skills

Regulatory knowledge

English proficiency

Ukrainian proficiency

Education

Bachelor's degree or higher

Job description

Kenvue is currently recruiting for a:

Regulatory Affairs Senior Specialist

What we do

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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. For more information , click here .

Role reports to:

HEAD OF REGULATORY AFFAIRS CEE/R&D SITE LEAD WARSAW

Location:

Europe/Middle East/Africa, Ukraine, Kyyivs'ka, Kiev

Work Location:

Hybrid

What you will do

The Senior Regulatory Affairs Specialist has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan,
• Manages 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,
• Maintains compliance for all products with local regulations and quality system requirements,

The Roles & Responsibilities include:

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 undefined 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 locallyEnsures 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

Specific requirements:

• 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 undefined
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Proficiency in English and Ukrainian

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.