Description
Kenvue is currently recruiting for:

Regulatory Affairs Analyst
This position reports into Regulatory Affairs Manager and is based at Sao Paulo or Sao Jose dos Campos.

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®, 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.

Role reports to: Regulatory Affairs Manager
Location: Sao Paulo or Sao Jose dos Campos
Travel %:
Pay: (If compliant with country laws)

What you will do
The Regulatory Affairs Analyst is responsible for ensuring compliance with regulatory agency regulations and interpretations, preparing responses to regulatory agencies' questions and other correspondence, organizing and maintaining reporting schedules for new drug application and investigational new drug applications, and providing solutions to a variety of problems of moderate scope of complexity:
Key Responsibilities

• Develop and maintain regulatory strategies and submissions for new and existing products in alignment with regulatory requirements and guidelines.

• Provide guidance and support to cross-functional teams on regulatory matters, including labeling, advertising, and promotional materials.

• Conduct regulatory research and analysis to ensure compliance with applicable laws and regulations.

• Collaborate with internal and external stakeholders to ensure timely and accurate submission of regulatory documents.

• Participate in regulatory agency meetings and negotiations as needed.

• Maintain up-to-date knowledge of regulatory requirements and industry trends.

• Contribute to the development and implementation of regulatory policies and procedures.

• Ensure compliance with all applicable regulatory requirements and guidelines.

• Lead the development and execution of regulatory strategies to ensure timely and successful submissions of new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies

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

• Ensure compliance within the department by developing and implementing global, regional, and local processes, policies, SOPs, and working instructions

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

• Develop timelines for submissions and monitor progress of applications against set timelines, taking action where necessary to minimize delays and anticipate difficulties

• Communicate information and present status updates on product/project activities to key internal/external stakeholders

• Lead the development of best practices for Regulatory Affairs processes

• Provide solutions to a variety of problems of moderate scope and complexity

• Maintain and archive regulatory documentation (as appropriate)

• Assist in the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides

• Stay up-to-date with regulatory agency regulations and guidelines and provide guidance to cross-functional teams

Qualifications
What we are looking for
Required Qualifications

• Bachelor's degree in a related field, such as life sciences, pharmacy, or chemistry.

• 2-4 years of experience in regulatory affairs or a related field.

• Strong knowledge of regulatory requirements and guidelines.

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

• Attention to detail and ability to manage multiple projects simultaneously.

• Ability to adapt to changing priorities and deadlines.

• 2-4 years of experience in handling regulatory data on regulated products such as OTC Drugs, Cosmetics and Medical Devices

• University/Bachelors Degree or Equivalent in a relevant field

• Excellent computer skills in Word, Excel, Power Point, Email, and Internet are required

• Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems

Desired Qualifications

• Strong analytical and problem-solving skills.

• Experience of Regulatory processes such as Drug Listing, IDMP and Periodic Safety Reporting

• Strong and effective interpersonal skills, with a team-oriented and collaborative approach geared towards providing solutions and consistent delivery

• Ability to multi-task and deliver high quality work under pressure to deliver results

• Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans and strong track record seeking and incorporating stakeholder feedback

What’s in it for you

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

• Competitive Benefit Package*

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & 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.

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.

Primary Location Latin America-Brazil-São Paulo-São José dos Campos

Job Function Regulatory Affairs