Senior Regulatory Affairs Specialist Strategy & Submissions

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 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.