Sr. Regulatory Affairs Analyst - São José dos Campos, Brasil - Kenvue

Descrição

Kenvue is currently recruiting for:

Specialist Sr, Regulatory Affairs

This position reports to LATAM CMC Regulatory Affairs Manager and is based at Sao Paulo.

Who we are

At , 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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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, .

What you will do

The Specialist Sr, Regulatory Affairs is responsible to manage/develop the successful coordination, compilation, submission and approval of New Drug Applications, Abbreviated New Drug Applications and Investigational New Drug applications to Latam Health Authorities, as well is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence.

Key Responsibilities

·This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval.

·Execute CMC regulatory strategies with internal research and development, and other technical/scientific colleagues

·Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.

·Develop and implement regulatory strategies for new and existing products in compliance with local and international regulations.

·Provide regulatory guidance and support to cross-functional teams.

·Prepare and submit regulatory submissions to health authorities.

·Monitor and communicate changes in regulatory requirements to ensure compliance.

·Collaborate with internal and external stakeholders to ensure regulatory compliance throughout the product life cycle.

·Contribute to the development and maintenance of regulatory policies and procedures.

·Provide regulatory training and support to colleagues as needed.

·Lead and manage regulatory activities for new drug applications, abbreviated new drug applications, and investigational new drug applications.

·Develop and maintain reporting schedules for new drug application and investigational new drug applications.

·Identify and implement best practices for Regulatory Affairs processes to improve efficiency and effectiveness.

·Provide solutions to a variety of problems of moderate scope and complexity.

·Ensure quality and compliance in all actions.

What we are looking for

Required Qualifications

·Bachelor's Degree or Equivalent in a relevant field

·2 years+ of experience authoring and compiling all parts of Module 3 CMC sections is required..

·A minimum of 4 years of pharmaceutical industry experience is required.

·Strong knowledge of local and international regulations.

·Experience with regulatory submissions and agency interactions.

·Ability to work independently and as part of a team.

·Strong attention to detail and organizational skills.

·Ability to manage multiple projects and priorities.

Desired Qualifications

·Advanced English Skills.

·Previous experience with global products(small molecule / NCE) is preferred.

What's in it for you

·Annual base salary for new hires in this position takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.

·Competitive Total Rewards Package*

·Paid Company Holidays, Paid Vacation, Volunteer Time & More

·Learning & Development Opportunities

·Employee Resource Groups

·This list could vary based on location/region

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.