Job Information
J&J Family of Companies Manager, Regulatory Affairs Process Support, Data Integrity and Compliance in Ciudad de Mexico, Mexico
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, trainings and communication to LATAM RA teams on RA data tracking requirements in global systems
-Coordinate/provide LATAM input on global RA data tracking systems, tools, requirements, projects and processes
-Provide support and advice to local and regional RA teams in LATAM on efficient and compliant use of RA data systems and tools.
Regulatory Affairs Compliance
-Ensure an adequate level of compliance in LATAM RA
-Coordinate LATAM RA contributions to global audits
-Provide support and coordination to LATAM RA teams for LOC audits and inspections, as needed
-Act as the LATAM RA contact for Global Regulatory Affairs (GRA) teams and other functions on RA compliance related topics and interpretation of local regulatory requirements
-Support and advise local and regional RA teams in LATAM on procedural document related requirements as well as the maintenance, review and applicability of these documents
-Advise local and regional RA teams in LATAM on management of non-conformances, CAPAs, quality or compliance issues, as needed.
Qualifications / Requirements:
-At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including activities in a regulatory compliance or GxP environment
-Excellent understanding of pharmaceutical Marketing Authorisation regulatory procedures and data in LATAM countries
-Understanding of regulatory data planning and tracking processes as well as information systems
-Knowledge of RA compliance requirements and advanced process thinking
-Good technical skills and computer proficiency
-Proven ability to monitor multiple actions and timelines and follow up until timely completion
-Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
-Excellent cross-cultural interpersonal skills
-Ability to communicate effectively in English, verbally and in writing
-Flexibility and proactivity
-Team-player
-Native/advanced Spanish or Portuguese, advanced English (required)
Other requirements
-Reachable during LATAM office hours and outside office hours in case of emergencies
-Flexibility for limited travel