Associate, RSMO submission manager

Associate, RSMO submission manager

Preferred locations : High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands) or Switzerland

Pay Grade : 24

Janssen Pharmaceutical Companies, a Johnson & Johnson company, is recruiting for an Associate, Submissions Management to be located in Europe (Leiden, Netherlands; High Wycombe, UK; or Beerse, Belgium). with experience in planning and publishing 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).

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.

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. The Associate will mainly support immunology submissions. Please visit http://www.janssen.com for more information.

The 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 Original 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 enhancements, and associated training materials
• May create and/or sign specific submission documents or publish dossiers according to regulatory requirements for paper and electronic submissions.

Qualifications

Qualifications:

• A minimum of a bachelor’s degree in combination with 0-3 years of relevant/related professional experience.
• 1-3 years 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.
• Ability to learn/use Regulatory Information Systems planning tools is required.
• Ability to facilitate small meetings.
• Demonstrated project or submission management capabilities is a plus.
• Knowledge of submission related HA and industry regulations is a plus.
• Fluency in English; other languages may be required depending on assignment.
• This position is to be located in Europe (Leiden, Netherlands; High Wycombe, UK; or Beerse, Belgium) and 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.

Primary Location
Netherlands-South Holland-Leiden- Other Locations
Switzerland, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe
Organization
Janssen Biologics (7266)
Job Function
Regulatory Affairs
Requisition ID
00001GYT