Experienced Regulatory Affairs Specialist

Overview

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

Buenos Aires, Argentina; Las Condes, Santiago; Region Metropolitana de Santiago, Chile

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

We are searching for the best talent for Experienced Regulatory Affairs Specialist to be in Buenos Aires, Argentina or Santiago, Chile.

Purpose

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 Argentina, Chile, Uruguay, Paraguay and Bolivia focused on labeling process. Accountability : Execution of the complete LCM regulatory process related to labeling updates. This includes ensuring the accuracy of assessments, dossier preparation, timely submission, and securing approvals, while maintaining compliance with all relevant regulations.

You will be responsible for

• Prepare submission-ready dossier based on local requirements and J&J standards and procedures.
• Ensure assessment, submission and approval of labeling variations in a timely manner.
• Be first point of contact for LCM with the local Regulatory Affairs colleagues.
• Align the labeling according to local strategy.
• Handle any Health Authority query for LCM submissions with applicable stakeholders.
• Notify deviation request for labeling to RMC coordinator and applicable stakeholders.
• 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.

Qualifications / Requirements

Education

University degree or related experience in Pharmaceutical Sciences

Experience and Skills

Required

Approximately 2-3 years of regulatory experience in pharmaceuticals or similar 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 handling life cycle and safety labeling variations.

Preferred

Experience handling life cycle and safety labeling variations in Argentina, Chile, Uruguay, Paraguay and Bolivia is desired.

Language

Proficient in Spanish; intermediate / advanced English is required.

Competencies

Required Skills

English Language, Regulatory Experience

Preferred Skills

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

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