Latam CMC Regulatory Affairs Jr Specialist

Latam CMC Regulatory Affairs Jr Specialist

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

MANAGER REGULATORY AFFAIRS

Locatie:

Latin America, Brazil, Sao Paulo, Sao Paulo

Werklocatie:

Hybride

Wat je gaat doen

Kenvue is currently recruiting for:

Latam CMC Regulatory Affairs Jr Specialist

This position reports to Latam CMC Regulatory Affairs Manager and is based at São Paulo.

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® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the 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. For more information, click here.

Role reports to: Latam CMC Regulatory Affairs Manager

Location: São Paulo

Travel %: 10

What you will do 

The Regulatory Affairs Jr Specialist 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 the Latam Health Authorities:

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

What we are looking for

Required Qualifications

• A minimum of a bachelor’s degree in relevant health-related scientific discipline
• 6 months+ of experience authoring and compiling all parts of Module 3 CMC sections is required
• A minimum of 6 months of pharmaceutical industry experience is required

Desired Qualifications

• Intermediate-Advance English skills
• Previous experience with global products (small molecule/NCE) is preferred

What’s in it for you

• Annual base salary for new hires in this position ranges from $XXX to $YYY.  This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.
• Competitive Total Rewards Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & 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 based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

Als u een persoon met een handicap bent, kijk dan op onze pagina Hulp bij handicap voor informatie over het aanvragen van een accommodatie.