Regulatory Affairs Specialist - São Paulo-SP

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:
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

We are searching for the best talent for We are searching for the best talent  for Regulatory Affairs Specialist - São Paulo-SP



* Under supervision, it is responsible for regulatory activities to support and grow the business in line with the company goals.

This includes:

Principal Responsibilities:

Regulatory Policy & Intelligence:


* Shapes & influences the regulatory environment including working on or commenting on Health Authority new regulations, future regulations and new approaches for current regulations through participation in discussion groups Trade Association as a team member.


* Participates in the Trade Associations working groups and meetings.


* Work with Regional Office within J&J and CMCs, as appropriate for new and/or updated Regulations that may impact.

Regulatory Strategy


* Prepare and submit regulatory submissions (e.g.

ANVISA database corrections, DCB request, labeling notifications, leaflet notifications, variations, registration submissions amendments etc) and HA queries timely;


* Contribute to compliance with all regulatory requirements (e.g.

timely submission of dossiers, timely implementation of new national and international legislation, timely implementation and training of SOP’s & supporting systems) and regulatory systems;


* Regulatory Intelligence review for the products;


* Review promotional materials;


* Contributes with the regulatory strategy of new business projects for Brazil, including Marketing Authorization Holder Transfer and other Special Projects;


* Dossier evaluation for pending requirements identification using the gap analysis spreadsheet and calls with Regional Office to expedite pending information/documentation receipt; Interacts and aligns with internal/local business partners (e.g.

Medical Affairs, Marketing, Supply, CMC-RA, etc) t...