Senior Regulatory Affairs Program Lead - Mentor, LLC

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:
Irving, Texas, United States of America

Job Description:

We are searching for the best talent for a Senior Regulatory Affairs Program Lead to be based in Irving, TX.  This role will support our Mentor business unit.

Purpose: The Senior Regulatory Affairs Program Lead is responsible for partnering with R&D, Life Cycle Management (LCM), Supply Chain, Quality Engineering, Global Strategic Marketing, and other key cross-functional leaders to develop and execute robust global regulatory strategies focused primarily on LCM guidance and projects for both of our manufacturing facilities.  The successful candidate will provide regulatory guidance to product development teams in strategic planning and related submissions to support optimal timelines for modified product launches, cost savings and other business initiatives.  Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.  The Senior Regulatory Affairs Program Lead helps to define data and information needed for regulatory approvals in conjunction with cross-functional LCM  teams.  The role assists in the development of best practices for Regulatory Affairs processes. 

You will be responsible for: 


* Strategic partner with key cross functional colleagues to develop and execute global regulatory strategies and timelines for existing products to assure on-time regulatory approval/clearance and post-marketing activities while mitigating supply disruptions.


* Reviews product design, labeling, and manufacturing changes to existing products to assess the impact to safety and efficacy as needed.


* Ensures compliance with regulatory agency regulations and interpretations.


* Defines, gathers and assembles data necessary for submissions in accordance with regulations and relevant guidelines while partnering with other functions.


* Prepares responses to regulatory agencies' questions and other correspondence.


* Provides regulatory advice to project teams and recommends solutions to complex problems in which data analysis requires an evaluation of intangible variables.


* Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to ...