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 Analyst (2407028271W)Regulatory Affairs AnalystThis position reports into Regulatory Affairs Manager and is based at Sao Paulo or Sao Jose dos Campos.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 delivering the best products to our customers.What you will doThe 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 ResponsibilitiesDevelop 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.QualificationsRequired QualificationsBachelor'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.Excellent computer skills in Word, Excel, PowerPoint, Email, and Internet are required.Attention to detail with excellent documentation skills and ability to continuously anticipate and solve problems.Desired QualificationsStrong 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.What's in it for youAnnual 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.Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!Learning & Development Opportunities.Employee Resource Groups.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.
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