Manager, Regulatory Affairs Process Support, Data Integrity and Compliance

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:
Bogotá, Distrito Capital de Bogotá, Colombia, Ciudad de Mexico, Mexico, São Paulo, Brazil

Job Description:

 

About Innovative Medicine 

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

#Li-Hybrid

We are searching for the best talent for Manager, Regulatory Affairs Process Support, Data Integrity and Compliance to be in Mexico, Colombia or Brazil.

Purpose:

This role provides regional leadership in the Regulatory Affairs (RA) areas of process support, data integrity and compliance to the RA teams in the LATAM region.

The role partners closely with regional and LOC RA teams in LATAM, as well as with cross-regional and global stakeholders in the GRA organization, to deliver sustainable solutions and support addressing stakeholder needs.

This role will also connect with relevant cross-functional partners in the region, e.g.

Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.

This role is a member of the cross-regional Regulatory Affairs Process Support, Data Integrity and Compliance team and a key contributor to the team's success.

You will be responsible for:

Regulatory Affairs Process Support

-Provide strategic support and tactical advice to local and regional RA teams in LATAM on optimal and compliant application of RA procedures and processes, including implementation of new regulatory requirements
-Facilitate LATAM RA input into global/regional processes and procedures impacting LATAM RA teams, partnering with assigned Substance Matter Experts (SMEs) as applicable
-Ensure, coordinate, develop and/or deliver (as needed) training and communication on RA processes for LATAM, in collaboration with assigned business process owners and SMEs
-Identify and drive prioritized process improvement opportunities in LATAM RA.

Regulatory Affairs Data Integrity

-Ensure robust tracking of agreed LATAM RA data in global tracking systems and tools
-Provide guidance, tra...