The position will preferably be based in Raritan NJ; flexible arrangements for other sites locations could be discussed but would require the candidate’s flexibility to travel to this site when necessary.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular, metabolic, and retinal diseases. Please visit http://www.JanssenRnD.com for more information.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
The Senior Director, Global Regulatory Leader, Gene Therapy will be responsible for the development, implementation and maintenance of global regulatory strategies for transformational therapies (gene therapy and/or small/large molecules) targeted to restore and preserve vision in patients with retinal diseases.
AS SENIOR DIRECTOR, GLOBAL REGULATORY LEADER (GRL), YOU WILL:
- Bring innovative regulatory approaches, deeply rooted in science to lead the team in discussion with global health authorities to find the best development strategies for novel therapies in the areas where no other precedents exist.
- Be responsible for the development, implementation and maintenance of robust global regulatory strategies for transformational therapies targeted to address unmet needs in retinal diseases in different phases of development.
- Drive the execution of the regulatory strategies for select projects through close collaboration with functional areas and ensure the regulatory strategies are aligned with the overall Therapeutic Area strategy.
- Lead the Global Regulatory Team (GRT) and contribute effectively on multiple cross-functional teams including but not limited to the Compound Development Team, Global Dossier Team, Clinical Working Group, and the Labeling Working Group.
- Ensure that regulatory strategies also take into account non-regulatory market access issues (e.g., health technology assessments, payor demands)
- Ensure, facilitate and/or lead the development or enhancement of constructive relationships and associations with Health Authorities and thought leaders in appropriate business critical settings.
- Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.
- Lead the preparation and participate in meetings with FDA, EMA, PMDA, CDE, Health Canada and other Health Authorities (HAs) as required.
- Serve as a member of LWG to create or update the CCDS and contributes 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.
Qualifications
QUALIFICATIONS
- Minimum of a B.S. in a life sciences or technical discipline is required
- An advanced degree is preferred (e.g., M.S., Ph.D., M.D.)
- A minimum of 15 years in drug development any of the following areas (e.g. Global Regulatory Affairs, R&D or health authority role) is required.
- Strong preference for candidates successfully working on advanced therapies (gene and cell therapies)
- Minimum 5 years of recent regulatory affairs leadership role required
- A track record of innovative thinking and application is required
- Significant experience in the development and execution of global regulatory strategies, the drug development process, regulatory compliance, and regulatory strategy for product lifecycle management is required
- Experience establishing productive working relationships with Health Authorities and gaining a deep understanding of how regulators view certain drug development issues is required
- Experience leading a matrixed global team of diverse individuals is required
- Experience leading direct reports and being responsible for their development is required
The position will preferably be based in Raritan, NJ, but flexible arrangements for other site locations maybe considered. Will be required to travel up to 20% domestic and internationally.
Primary Location
United States-New Jersey-Raritan-
Other Locations
United States, United States-Massachusetts-Boston, United States-Pennsylvania-Philadelphia, United States-Washington-Seattle, United States-New Jersey-Raritan, United States-Pennsylvania-Horsham, United States-California-San Diego, United States-California-San Francisco, United States-District of Columbia-Washington, United States-Florida-Jacksonville, United States-Florida-Miami, United States-New Jersey-New Brunswick, United States-New Jersey-Titusville, United States-New York-New York, United States-Pennsylvania-Spring House
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
9696200805
Source: Indeed.com
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