HireDiversity

Raritan, NJ, US

Regulatory Professional-6762130110

Description

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Regulatory Professional, specifically in the area of Oncology, to be based in Raritan, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The company's oncology portfolio includes approved and pipeline development projects (e.g. Zytiga, ibrutinib, Velcade, Siltuximab and Yondelis).

The Regulatory Professional will provide support to Regulatory Leaders in regards to all activities for compounds that are either in development or for Janssen marketed products specifically to the Oncology portfolio. Under the direction of the Regulatory Leaders, the Regulatory Professional will be responsible for preparing or contributing to IND, NDA and eCTD dossier filings and related submissions including preparation of meeting packages and responses to Health Authority inquiries as delegated. This position requires knowledge of local regulations and submission requirements for lifecycle submissions such as protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs. Additionally, the Regulatory Professional will be responsible for the critical review of submission documents and will ensure compliance with regulatory requirements. This position may also provide regulatory input for, and provide appropriate follow-up to inspections, audits and product complaints. The Regulatory Professional may serve as the Regulatory representative on specific multi-disciplinary teams, organizing and chairing meetings when appropriate. The Regulatory Professional will help develop strategy by researching regulatory and medical information in preparing submissions to regional Health Authorities. Additionally, the Regulatory Professional will assist with reviewing and interpreting related current Health Authority guidance's and assist with Advisory Committee meetings. This position will work with the Regulatory Leaders to understand the competitive landscape, Health Authority perspectives, regulatory precedents, labeling differences and therapeutic area issues, potentially on a global scale. This role may also provide input to Standard Operating Procedure documents to ensure accuracy and compliance to Regulatory Standards.

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Qualifications


A Bachelor's degree is required for this position. Knowledge of laws and regulations related to submissions and of filing registration process is required. Understanding of IND, NDA, and eCTD dossier component requirements is required. The ability to critically review and compile IND, NDA & eCTD dossier components is required. This role also requires knowledge of how Health Authorities operate, along with an understanding of the drug development process, submission requirements for lifecycle submissions (e.g., protocol amendments, information amendments, annual reports, PSUR's, and renewal applications). Knowledge of Microsoft programs is required and electronic management systems such as ERIS and GRAIL is highly desired. A basic medical/scientific understanding in a clinical area is required as well as proficient writing and grammatical skills. An understanding of the competitive landscape (e.g., views of Health Authorities, regulatory precedence, labeling differences and therapeutic areas) is a preferred skill, along with knowledge of laws, guidances and requirements and their implications related to specific therapeutic areas. Oncology experience is a plus. The ability to think analytically, communicate well, collaborate with internal and external partners, a demonstrated concern for quality and order, and the ability to take initiative are all requirements for this position. Three or more years experience in a similar role is highly desired. This position is based in Raritan, NJ.

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Primary Location:North America-United States-New Jersey-Raritan
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Regulatory Affairs