Regulatory Affairs Specialist

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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...