Kenvue is currently recruiting for a:
Senior Regulatory Affairs 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:
Senior Regulatory Affairs Manager
Location:
Europe/Middle East/Africa, Turkey, Istanbul, Istanbul
Work Location:
Hybrid
What you will do
Kenvue is currently recruiting for:
Regulatory Affairs Specialist
This position reports into Senior Manager Regulatory Affairs and is based at Istanbul, Turkey
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®, 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.
What you will do
Key Responsibilities
- Ensures compliance especially with cosmetics regulations, and additionally with medicine, medical device, food supplement, and general product regulations where applicable.
- Ensure compliance with Türkiye regulatory frameworks, especially cosmetics and medicines regulations, including ÜTS submissions, claim assessment, promotional material control, and interpretation of PO requirements, while collaborating with cross-functional teams and acting as the regulatory contact point for Turkish authorities and external stakeholders.
- 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 evaluates 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, seeking opportunities to expedite regulatory approvals where possible.
- Prioritizes, plans and monitors allocated projects against defined timelines
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements
- Prepares responses to regulatory agencies' questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.
- Ensures that all assigned products comply with local regulatory and quality system requirements.
- Reviews and approves promotional materials for assigned to local products.
What we are looking for
Required Qualifications
- Bachelor’s Degree in Chemistry, Chemical Engineering, Pharmacy, Biology, or Biomedical Sciences
- Minimum 6 years regulatory experience, preferably in cosmetics and consumer healthcare
- Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
- In-depth knowledge of Türkiye regulatory frameworks, including ÜTS processes and local medicines/cosmetics regulation
- Hands-on experience with claim assessment and promotional material control in compliance with Turkish regulations
- 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
- Excellent knowledge of required regulatory frameworks including medicines regulation and/or cosmetic regulation as a minimum within their geographic area of responsibility
- Broad knowledge of consumer healthcare environment and product development
- Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
- Strong interpersonal skills; able to build effective personal networks internally and externally.
- Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
- Strong organizational and time management skills with an ability to work under pressure.
- Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic,
- Results-driven environment.
- Able to work effectively in a multi-cultural, highly matrixed organization
- Excellent proficiency in English
What’s in it for you
- Competitive Package
- Learning & Development Opportunities
- Kenvuer Impact Networks
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit 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.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
