Sr. Regulatory Affairs Analyst

1 semana atrás

São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro
Sr. Regulatory Affairs Analyst W Description

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.

Qualifications

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.

  • Sr. Regulatory Affairs Analyst

    1 semana atrás

    São José dos Campos, São Paulo, Brasil J&J Brazil Tempo inteiro

    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 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,...

  • Sr. Regulatory Affairs Analyst

    1 semana atrás

    São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiro

    Working with UsChallenging. Meaningful. Life-changing. Those words aren't commonly associated with a job. But at Bristol Myers Squibb, things are far from ordinary. Here, every department experiences unique and interesting work daily. From optimizing production lines to groundbreaking advancements in cell therapy, the work done here positively impacts...

  • Regulatory Affairs Sr. Analyst

    1 semana atrás

    São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiro

    Regulatory Affairs Sr. Analyst (Synthetic products)Category:Reg Affairs & Safety PharmacovigilanceLocation:São Paulo, São Paulo, BR-The Position- Your responsabilities includes: Spearhead the development and expertise in synthetic molecules category, contributing to internal and HQ discussions for implementing synthetic products in Brazil. Actively engage...

  • Regulatory Affairs Analyst

    Há 7 dias

    São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiro

    Regulatory Affairs Analyst (Clinical Trials)Category:Reg Affairs & Safety PharmacovigilanceLocation:São Paulo, São Paulo, BR-The Position- Your responsabilities includes: Develop Informed Consent Forms and regulatory dossiers for initial submissions, amendments, and notifications. Manage the submission and approval process for trial dossiers, amendments,...

  • Regulatory Affairs Jr. Analyst

    1 semana atrás

    São Paulo, São Paulo, Brasil CEVA Animal Health, LLC Tempo inteiro

    Regulatory Affairs Jr. AnalystThe success of a company depends on the passionate people we partner with.Together, let's share our talents.As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing and supplying innovative health solutions for all animals, which...

  • Regulatory Affairs Consultant

    1 semana atrás

    São Paulo, São Paulo, Brasil Parexel Tempo inteiro

    Skills and knowledge:Regulatory Affairs Consultant should have solid local expertise in submitting Clinical Trials to Health Authority in Brazil.This role will be responsible for managing and coordinating the regulatory submission strategy for a large number of clinical trials in Brazil. Also, will coordinate and manage flow of information, track project...

  • Regulatory Affairs Analyst

    1 semana atrás

    São Paulo, São Paulo, Brasil Ferring Pharmaceuticals, Inc. Tempo inteiro

    Job Description:At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women's health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...

  • Regulatory Affairs Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiro

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will...

  • Regulatory Affairs Manager

    2 meses atrás

    São Paulo, São Paulo, Brasil Abbott Laboratories Tempo inteiro

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will...

  • regulatory affairs junior specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

    REGULATORY AFFAIRS JUNIOR SPECIALIST W Description Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science,...

  • Regulatory Affairs Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Edwards Lifesciences Tempo inteiro

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

  • Regulatory Affairs Consultant

    Há 7 dias

    São Paulo, São Paulo, Brasil Parexel Tempo inteiro

    timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Lead or Work Stream Lead, a consultant secures the work of the entire team or work stream is delivered on time and that it meets client's and PC's quality.Skills and knowledge:Regulatory Affairs Consultant should have solid local...

  • regulatory affairs specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Tempo inteiro

    REGULATORY AFFAIRS SPECIALIST W Description Kenvue is currently recruiting for: Regulatory Information Management (RIM) Specialist This position reports into Manager, Global Reg Strategic Compliance and is based at Brazil.- São Paulo Capital. Who we are At , we realize the extraordinary power of everyday care. Built on over a century of heritage...

  • Head of Regulatory Affairs Brazil

    1 semana atrás

    São Paulo, São Paulo, Brasil Novartis Tempo inteiro

    390635BRHEAD OF REGULATORY AFFAIRS BRAZIL - SSO - IM - SP:BrazilSobre o papelWork Model:HybridLocality:São PauloAbout the Role:1,800+ associates. 85+ countries. 1 goal. At Novartis, we are dedicated to discovering and developing new treatments for diseases including cancer, heart disease, and neurological conditions—and delivering them at a scale to reach...

  • Regulatory Affairs Junior Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil J&J Brazil Tempo inteiro

    Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo .Who we are 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,...

  • Regulatory Affairs Junior Specialist

    1 semana atrás

    São Paulo, São Paulo, Brasil Kenvue Inc Tempo inteiro

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - REGULATORY AFFAIRS JUNIOR SPECIALIST W) REGULATORY AFFAIRS JUNIOR SPECIALIST W Description Kenvue is currently recruiting for: Latam CMC Regulatory Affairs Jr Specialist This position reports to Latam CMC Regulatory...

  • Regulatory Affairs Manager Latam

    1 semana atrás

    São Paulo, São Paulo, Brasil Merck KGaA Tempo inteiro

    Work Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

  • Senior Regulatory Affairs Specialist

    Há 7 dias

    São Paulo, São Paulo, Brasil The BIG Jobsite Tempo inteiro

    Product Steward who have the overall coordination to manage product stewardship reviews (e.G GHS regulations), existing and emerging regulations, labelling and other requirements which comprehends Latin America region. These activities may include the development of safety data sheets and cross functional trainings;Ensure company operatesin conformity with...

  • Regulatory Analyst

    Há 7 dias

    São Paulo, São Paulo, Brasil CloudWalk Tempo inteiro

    If you have fallen and risen, if you have broken and fixed, if you have dreamt and built, then you have grit. Then we speak the same language. Welcome to the Wolfpack.About CloudWalk:We are one of the fastest growing fintechs on the planet. We kick ass. A unicorn, with millions of happy customers, a hardcore team, and hundreds of millions in funding and...