Regulatory Affairs Specialist

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:
Panama, Panamá, Panama

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 https: //www.jnj.com/

We are searching for the best talent for this Regulatory Affairs Specialist , based in Panamá City.

Purpose: The Regulatory Affairs Specialist supports the development and execution of regulatory strategies to enable timely product registration, approval, commercialization, and lifecycle management, while ensuring compliance with applicable local and international regulatory requirements and company standards.

Key Responsibilities

- Implements regulatory strategies and ensures compliance with applicable regulatory requirements by providing regulatory knowledge and guidance to support the development, manufacturing, registration, importation, commercialization, and lifecycle management of products.
- Analyzes and interprets regulatory requirements, scientific information, and product data to identify regulatory risks, opportunities, and potential pathways, providing recommendations that support timely product approvals and market access.
- Supports the development and execution of regulatory strategies for new product registrations and indications.
- Plans, prepares, reviews, and coordinates high-quality regulatory submissions for new and existing products, ensuring completeness, accuracy, consistency, and timely submission to Health Authorities.
- Coordinates responses to Health Authority questions and requests for information, working cross-functionally to obtain the necessary scientific, technical, clinical, quality, and administrative documentation.
- Maintains regulatory approvals and product registrations throughout the product lifecycle, proactively monitoring commitments, renewal requirements, variations, labeling updates, and other regulatory obligations.
- Provides regulatory expertise to cross-functional teams, partnering with Medical Affairs, Quality, Supply Chain, Commercial, Market Access, Pharmacovigilance, Legal, and other functions to ensure regulatory requirements are appropriately incorporated into business and operational plans.
- Reviews product labeling, claims, promotional and scientific materials, and related communications, providing regulatory input to ensure alignment with approved product information, applicable regulations, and internal standards.
- Monitors the regulatory environment and emerging requirements, assessing potential impact on products, submissions, and business activities and communicating relevant regulatory intelligence to key stakeholders.
- Supports interactions and communications with Health Authorities, including preparation of regulatory documentation, responses, scientific justifications, and meeting materials, as applicable.
- Identifies opportunities to improve regulatory processes and ways of working, contributing to greater efficiency, quality, consistency, and regulatory compliance.
- Supports internal and external audits and inspections by providing regulatory documentation, records, assessments, and subject-matter expertise as required.
- Maintains accurate and up-to-date regulatory records, databases, trackers, and documentation, ensuring appropriate traceability of submissions, approvals, commitments, and correspondence with Health Authorities.
- Demonstrates ownership and accountability for assigned regulatory activities, proactively identifying risks, communicating potential delays, and escalating issues when necessary to support business continuity and regulatory compliance.
- Shares regulatory knowledge and best practices and provides guidance to junior colleagues, supporting capability development and consistent execution across the team.
- Works in accordance with Johnson & Johnson’s Credo, applicable compliance requirements, and leadership expectations, demonstrating integrity, collaboration, accountability, and a patient- and customer-focused mindset.

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Key Competencies

- Strong knowledge of regulatory requirements and product registration processes.
- Ability to interpret scientific, technical, clinical, and regulatory information.
- Regulatory strategy and problem-solving capabilities.
- Strong planning, organization, and project management skills.
- Ability to manage multiple regulatory activities and priorities simultaneously.
- Effective written and verbal communication skills.
- Ability to collaborate effectively in cross-functional and multicultural environments.
- Strong attention to detail while maintaining a broader business perspective.
- Proactive identification and management of regulatory risks.
- Ability to communicate complex regulatory topics clearly to non-regulatory stakeholders.
- Continuous improvement and learning mindset.

Required Skills:

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