Sr Analyst, Regulatory Affairs

Sr Analyst, Regulatory Affairs

What we do

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are 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 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, click here.

Role reports to:

COORD ASSUN REGUL

Location:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Work Location:

Hybrid

What you will do

The Sr Analyst, 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

• Serve as the LATAM CMC Operations Subject Matter Expert (SME), leading the authoring, review and compilation of CTD Module 3 dossiers for regulatory submissions across LATAM markets, providing technical guidance on CMC regulatory requirements and lifecycle management activities, while mentoring colleagues and driving knowledge sharing and best practices across the organization
• 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
• 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 in Pharmacy, Chemistry, Chemical Engineering or related scientific field.
• Solid experience authoring and compiling all parts of Module 3 CMC sections is required
• Solid experience of pharmaceutical industry experience is required
• Demonstrated experience supporting submissions and regulatory interactions with LATAM Health Authorities, including ANVISA, COFEPRIS and other regional agencies.
• Strong knowledge of pharmaceutical manufacturing processes, analytical methods, specifications and lifecycle management activities.
• 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
• Intermediate to advanced English proficiency (written and verbal).
• Proven ability to mentor and train colleagues on regulatory CMC topics.

Desired Qualifications

• Intermediate to advanced Spanish proficiency.
• Experience supporting global products and global submission programs.
• Experience working in a regional LATAM role.
• Experience with small molecules and NCE products.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.