Director, Global Regulatory Leader (GRL) (1 of 2)

Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader (1 of 2) located in New Jersey or Pennsylvania.

At Johnson & Johnson, we are working to create a world without disease.

Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science.

We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com .

Key Responsibilities:


* Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health Authorities globally to find the best development strategies for novel therapies in the areas where no other precedents exist


* Integrate multiple inputs from regional and functional Global Regulatory Team members to build coherent and unified regional regulatory strategies.


* Be responsible for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in neuroscience/neuropsychiatry in different phases of development


* Drive the execution of regulatory plan for select projects through close collaboration with multiple functional areas


* Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with regional teams, CMC, commercial strategies, and the Target Product Profile


* Ensure that regulatory strategies also consider non-regulatory market access issues (e.g., health technology assessments, payor demands)


* Lead the preparation of regulatory dossiers for submissions to US FDA.


* Lead the preparation and participate in meetings with Health Authorities (HAs) in US and OUS markets.


* Serve as a member of the Labeling Working Group to create or update the CCDS and contribute to the development of local labels as appropriate.


* Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label


* Ensure compliance with internal and external policies and legislation


* Support or lead Due Diligence activities as appropriate


* Results and Performance Driven/Initiative: Assumes personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities.

Education:


* A Bachelor's degree in a scientific field or Advanced degree (MS, PhD, MD or Pharm D) (preferred)

Experience and Skills:

Required:


* A minimum of 8 years' experience in either pharmaceutical industry, medical device industry, consumer industry or health authority regulated industry


* At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA


* Experience establishing ...