Analista Assuntos Regulatórios Sr (Fixed term 24 months) – Johnson & Johnson Consumer Health

Titulo da Vaga: Analista Assuntos Regulatórios Sr (Fixed term 24 months)

Localização: São Paulo – SP

Descrição da Vaga: DescriptionKenvue is currently recruiting for:Sr Analyst, Regulatory Affairs (Fixed Term 24 months)This position reports into Latam CMC Regulatory Affairs Manager and is based at São Paulo.Who we areAt 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® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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.What you will doThe 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 forRequired 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

• Competitive Benefit Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

*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.Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Nome da Empresa: Johnson & Johnson Consumer Health

Salário:

Candidatar-se a vaga!