RSI Manager Regulatory Affairs - São Paulo or Ciudad de México

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Mexico City, Mexico, São Paulo, Brazil

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Regional Strategic Implementation (RSI) is part of the Regional Regulatory Affairs organization within Global Regulatory Affairs and supports regulatory activities in Asia Pacific (AP), Latin America (LA) and the Emerging Markets of EMEA.

The team efficiently and effectively executes regional strategies and leverages processes and resources across all regions.

We are therapeutically aligned and support the full lifecycle of products in all therapeutic areas.

We are searching for the best talent for We are searching for the best talent for RSI Manager Regulatory Affairs - São Paulo-SP or Ciudad de México-MX

Regional Strategic Implementation (RSI) is part of the Regional Regulatory Affairs organization within Global Regulatory Affairs and supports regulatory activities in Asia Pacific (AP), Latin America (LA) and the Emerging Markets of EMEA.

The team efficiently and effectively executes regional strategies and leverages processes and resources across all regions.

We are therapeutically aligned and support the full lifecycle of products in all therapeutic areas.

Scope of Responsibilities:



* For Marketing Authorization Applications, provides regulatory support throughout registration process and life-cycle management (e.g.

iCTDs, ACTDs, renewal applications, Health Authority Responses, site registrations and routine marketed product submissions including PSURs, RMPs).


* Advises team on required documents in preparation of submissions as assigned in collaboration with RSI Lead.


* Assists with timely registration dossier availability, ensures that all document components are in place on time, identifies and tracks critical path activities;


* Compiles Module 1 for iCTDs to be dispatched to countries.


* Manages and tracks the assembly of country-specific submission packages to the LOCs in accor...