Experienced RA Professional Lifecycle Submissions LATAM

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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: