Senior Regulatory Affairs Specialist

1w1 week ago

Kenvue

Istanbul, TR · Full-time · TRY 250,000 – TRY 450,000

About this role

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®. Science is our passion; care is our talent.

This Senior Regulatory Affairs Specialist role reports to the Senior Regulatory Affairs Manager in a hybrid location in Istanbul, Turkey. You will ensure compliance with regulations for medicines, medical devices, cosmetics, food supplements and general products. Key tasks include preparing submissions and monitoring authority reviews.

Our global team of ~22,000 brilliant people features 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 customers. Expertise and empathy define our collaborative environment.

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. Join us in shaping our future–and yours with brilliant opportunities.

Requirements

Knowledge of regulatory regulations for medicines, medical devices, cosmetics, food supplements and general products
Experience in coordinating and submitting regulatory applications to health authorities
Ability to evaluate regulatory requirements for quality, preclinical and clinical data
Proficiency in preparing regulatory submissions and dossiers
Skills in monitoring regulatory review processes and communicating with authorities
Competence in project prioritization, planning and timeline management
Understanding of regulatory environments in Europe, Middle East and Africa regions
Familiarity with interpretations of regulatory guidelines

Responsibilities

Ensure compliance with regulatory agency regulations such as medicines, medical devices, cosmetics, food supplements, general products and interpretations
Assist in the coordination, compilation and submission of new drug applications, cosmetics, medical devices, food supplements or similar products to regulatory agencies
Collect and evaluate information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations
Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines
Monitor the progress of the regulatory authority review process through communication with the Health Authority to expedite approvals
Prioritize, plan and monitor allocated projects against defined timelines
Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements
Prepare responses to regulatory inquiries