REGULATORY AFFAIRS SPECIALIST (Fixed Term 12 months)

Description

Kenvue is currently recruiting for:

Regulatory Affairs Specialist

This position reports into GRA CMC Regulatory Affairs Manager and is based at Mexico City.

Who we are

At Kenvue , part of the Johnson & Johnson Family of Companies, we believe there is extraordinary power in everyday care.

Built on over a century of heritage and propelled forward by science, our iconic brands-including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® and BAND-AID® -are category leaders trusted by millions of consumers who use our products to improve their daily lives.

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.

What you will do

The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence, and organizing and maintaining reporting schedules for new drug application and investigational new drug applications, this is a fixed term 12 months position.

Key Responsibilities:

• Develop and maintain regulatory strategies and submissions for new products and changes to existing products in alignment with industry standards and regulations.

• Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout the product development lifecycle.

• Provide guidance and support to internal stakeholders on regulatory matters, including labeling, advertising, and promotional materials.

• Stay up-to-date with changes in regulations and industry standards, and communicate potential impacts to the organization.

• Contribute to the development and implementation of quality systems and processes to ensure compliance with regulatory requirements.

• Participate in regulatory agency inspections and audits, and assist with the resolution of any findings or observations.

• Develop and execute regulatory strategies to ensure compliance with global, regional, and local regulations and guidelines

• Collaborate with cross-functional teams to plan, conduct, and manage regulatory activities to meet department and company objectives

• Prepare and compile high-quality regulatory submissions, responses to regulatory agencies questions, and other correspondence in accordance with regulatory agency regulations and guidelines

• Review and approve artwork and promotional copy material to ensure regulatory compliance

• Develop and maintain reporting schedules for new drug application and investigational new drug applications

• Provide solutions to complex problems and ensure quality and compliance in all actions

• Maintain and archive regulatory documentation in accordance with regulatory agency regulations and guidelines

• Present status updates on product/project activities to key internal/external...