Regulatory Affairs Manager

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 Manager (2307015323W)

Regulatory Affairs Manager - 2307015323W

Description

Kenvue is hiring a Regulatory Affairs Manager to be based in São Paulo.

Who We Are?

At Kenvue, we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes. Join us in shaping our future—and yours!

What will you do?

Manage/develop the successful coordination, compilation, submission and approval of New Drug Applications, Abbreviated New Drug Applications and Investigational New Drug applications to the LATAM regulatory agencies (ANVISA and Cofepris). 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.

Other activities include:

• 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.
• Provides direction regarding the regulatory requirements of Kenvue's new and marketed products, as well as helping support the implementation of long term companywide regulatory strategies and operating principles/practices.
• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
• Promote an environment of employee involvement in the workplace.
• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

What are we looking for?

• Bachelor’s degree in relevant health-related scientific discipline or an advanced degree in a related field is preferred.
• Fluency in English.
• 4+ years of experience authoring and compiling all parts of Module 3 CMC.
• 5+ years of pharmaceutical industry experience.
• Knowledge/familiarity with Brazil and Mexico regulatory registration of drugs.
• Experience interacting with health authorities.
• Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment.
• Ability to work independently, manage several complex projects/issues in parallel, and effectively influence others in a cross-functional team setting with a solution-oriented and enterprise mindset.
• Availability to work in a hybrid model based in São Paulo.

Preferred Qualifications:

• Previous experience with global products (small molecule/NCE.
• Fluency in Spanish.
• Regulatory Affairs Certification (RAC).
• Experience interacting with relevant trade associations or serving on trade association committees.
• Knowledge of the Office package (MS Word, MS Excel, MS Powerpoint).

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 identify, age, national origin, or protected veteran status and will not be discriminated against based on disability.

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Kenvue is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor 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.andEqual Employment Opportunity Posters GINA Supplement.

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