Jj
Regulatory Affairs specialist
Salary
Job description
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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Mexico City, MexicoJob 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
Position Summary
We are seeking a Regulatory Affairs professional to support lifecycle management (LCM) activities across LATAM, with a focus on Colombia, Ecuador, and Peru. This role is responsible for the end-to-end execution of post-registration regulatory processes, ensuring timely submissions, approvals, and compliance with local regulations and internal standards.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
Key Responsibilities
Execute end-to-end lifecycle regulatory processes for post-registration changes across assigned LATAM countries.
Prepare high-quality submission-ready dossiers aligned with local regulatory requirements and J&J standards.
Ensure timely assessment, submission, and approval of regulatory variations.
Act as the primary point of contact for lifecycle regulatory activities with local RA teams.
Manage and respond to Health Authority queries, ensuring accuracy and alignment with stakeholders.
Coordinate cross-functional collaboration (Regulatory Affairs, Quality, ArtWorks, and other stakeholders).
Maintain and update Regulatory Affairs systems and databases.
Ensure proper documentation and archiving of submissions and approvals.
Assess impact of new regulations and support implementation plans, identifying risks and opportunities.
Contribute to continuous improvement initiatives and knowledge sharing within the team.
Qualifications
Education:
Bachelor’s degree in Health Sciences, Biological Sciences, or a related field is required.
Experience & Skills
1 to 4 years of experience in the pharmaceutical industry (Regulatory Affairs or related areas).
Experience in lifecycle management, including labeling and CMC variations. (Preferred)
Strong understanding of regulatory submission processes and compliance. (Preferred)
Ability to work in cross-functional and regional environments.
Proactive, detail-oriented, and execution-focused mindset.
Strong analytical and problem-solving skills with ability to work independently.
Preferred:
Experience supporting multiple LATAM markets.
Familiarity with biological products regulations.
Language Requirements
Proficient in Spanish.
Intermediate English is required.
Core Competencies
Compliance and execution excellence.
Collaboration and teamwork mindset.
Adaptability to regulatory changes.
Strong communication skills.
Continuous improvement and innovation mindset.
Learning agility and curiosity.
Required Skills:
Preferred Skills:
Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented
