Scientist, Regulatory CMC Dossier

Janssen Research & Development , L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company.

At the Janssen Pharmaceutical Companies of 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with managerial guidance. The Scientist supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as assists the team lead in preparing responses to marketing applications with managerial guidance. Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions with managerial guidance. Ensures all Quality submissions are completed in a timely manner.

Responsibilities

* Lead and execute CMC writing for clinical applications (CTA, IND) and may participate in marketing applications (BLA, MAA) for biologics
* Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD
* Lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines
* Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities
* Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure
* Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development, and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables
* Resolves cross-functional issues
* Works mostly independently on a day-to-day basis