Experienced RA Professional Lifecycle Submissions LATAM
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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 Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Buenos Aires, Argentina, Las Condes, Santiago,, Region Metropolitana de Santiago, Chile, Mexico City, Mexico
Job Description:
Johnson & Johnson is recruiting for a Experienced RA Professional Lifecycle Submissions LATAM, to work in Cross-Regional Operations & Strategy Support (C-ROSS).
Position summary:
This is a Regulatory Affairs professional with local/regional responsibility. The role purpose is to be responsible for the end-to-end process execution of regulatory lifecycle management (LCM) in Chile, Argentina, Uruguay, Paraguay, Bolivia, and other LATAM countries, focused on post-registration process.
Accountability: Execution of the complete LCM regulatory process related to post-registration (variations) updates. This includes ensuring the accuracy of assessments, dossier preparation, timely submission, and securing approvals, while maintaining compliance with all relevant regulations.
Key Responsibilities:
Prepare submission-ready dossier based on local requirements and J&J standards and procedures.
Ensure assessment, submission and approval of life cycle variations in a timely manner.
Monitoring of Company regulatory submissions/approvals.
Be first point of contact for LCM with the local Regulatory Affairs colleagues.
Handle any Health Authority query for LCM submissions with applicable stakeholders, ensuring the robustness of the response.
Continuous communication, integration and alignment with local team (i.e. RA, Supply, CQ, AW responsible, etc) of the countries in scope.
Responsible for RA databases related to LCM.
Archiving all relevant documents from submissions and approvals.
Participate in meetings with different departments, contributing and adding knowledge.
Assessment of the impacts of new legislation, risks and opportunities and develop a robust plan for implementing new legislation.
Qualifications
Education:
Bachelor’s degree in Pharmacy or Biological Sciences is required.
Competencies
Strong focus on execution and compliance on submissions/approvals.
Adaptability to adjust to regulatory changes.
Effective Communication.
Analytical and data driven decision making (preferably without supervision).
One team culture and Collaboration within C-ROSS and all stakeholders.
Innovation and Continuous Improvement: skills in problem-solving, critical analysis, and the ability to identify and implement process improvements.
Agility and curiosity for continuous learning: Eagerness to learn and expand regulatory knowledge for other countries/clusters
Accountability
Experience and Skills:
Required:
Approximately of 3-4 years of regulatory experience in pharmaceuticals industry.
Proactive team player, able to take charge and follow-through.
Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
Experience of working in a virtual team and/or global organization.
Strong in data gathering, and interpretation with proficient use of technology including RA systems.
Previous experience with biological products and labeling updates is required.
Language:
Proficient in Spanish; Advanced English is required.
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
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 589 comparable Regulatory Affairs roles across 115 biopharma companies.
Salary context
157 of 589 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 589 comparable roles
+ 48 more countries
Seniority mix
456 of 589 peers have a known seniority level
Therapeutic area mix
44 of 589 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Open in 3 locations
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.