Biotech and Agricultural Creative and Design Medical and Healthcare
1 - 2 Years
Regulatory Associate, Submissions Management
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Regulatory Associate, Submissions Management with experience in planning and publishing clinical trial application submissions, major global marketing application submissions, and related lifecycle management to be part of the Regulatory Submissions Management and Operations team within Global Regulatory Affairs (GRA).
This position may be located in the United States (Cherry Hill, NJ, Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA;), Beerse, Belgium; Leiden, The Netherlands; Allschwil, Switzerland or High Wycombe, England and may be remote in one of these countries for the right candidate.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
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.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssen.com for more information.
The Regulatory Associate, Submissions Management collaborates with colleagues to ensure compliance with regulatory agency regulations and interpretation. This position coordinates and compiles dossier plans/submission packages, arranges review and approval of submission packages, and may publish/dispatch. The Associate may be responsible for the management and delivery of Clinical Trial Authorization (CTA) Applications, Original Marketing Authorization Applications as well as Lifecycle Submissions. Updating records information management systems is also a responsibility of the Associate. Special projects may be assigned and reviewed periodically.
In this role, you will:
Assist in the preparation of dossier plans/submission packages for products in line with regulatory strategy.
Interact with regulatory therapeutic areas, functional area representatives, facilitating meetings as needed.
Support development of departmental work practices, process improvements, and associated training materials
May build and/or sign specific submission documents or publish dossiers according to regulatory requirements for paper and electronic submissions.
A minimum of a bachelor’s degree is required
A degree in a scientific or technical discipline is beneficial
A minimum of 2 years of relevant/related professional experience is required
Previous experience in a health regulated industry is beneficial.
A minimum of 1 year of Regulatory Affairs experience is preferred.
Basic understanding of the drug development process is preferred.
Effective interpersonal, teamwork, and communication skills is required.
Demonstrated ability to work or lead in a matrix environment is required.
Previous experience or familiarity with Regulatory Information Systems planning tools is desired.
Previous experience or familiarity with Clinical Trial Authorization (CTA) Applications, and Original Marketing Authorization Applications as well as Lifecycle Submissions is very beneficial.
Previous experience facilitating small meetings is required.
Demonstrated project or submission management capabilities is a plus.
Knowledge of submission related Health Authority (HA) and industry regulations is a plus.
This position may be located in the United States (Cherry Hill, NJ, Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA;), Beerse, Belgium; Leiden, The Netherlands; Allschwil, Switzerland or High Wycombe, England. Remote flexibility may be considered. This role may require up to 5% travel domestic/internationally.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Pennsylvania-Philadelphia-863 N 25th St Other Locations
Europe/Middle East/Africa-Switzerland-Allschwil, United States-New Jersey-Raritan, United States-Pennsylvania-Horsham, United States-California-Los Angeles, United States-New Jersey-Titusville, United States-Pennsylvania-Malvern, United States-Pennsylvania-Radnor, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden, United States-California-San Francisco, United States-New Jersey-Cherry Hill Organization
Janssen Research & Development, LLC (6084) Job Function
Regulatory Affairs Requisition ID
Open Positions from Johnson & Johnson Family of Companies