Regulatory Affairs Jr Specialist

at  Johnson Johnson

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.
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 Cofepris:

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

Qualifications
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

• 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 setting