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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