Associate Director, CMC Dossier Development

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As the Associate Director, CMC Dossier Development, you are responsible for developing the technical eCTD sections (i.e., marketing applications, line extensions, clinical trial applications) and related CMC submissions (i.e., briefing books, Health Authority Responses) to support Regulatory CMC dossier applications. You also assume personal ownership and accountability for business results and solutions. And you represent the department on multi-functional project development teams to support regulatory filings. In this role you author/drive, as appropriate, sections of the CMC dossier and evaluate/ensure that final versions follow regulatory requirements and fulfill regulatory agency expectations. You establish and ensure adherence to timelines and coordinate and collect all necessary quality source documentation. You support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications. You evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submissions. Job Scope Owns, communicates and executes the CMC dossier strategy, in alignment with the regulatory strategy, and contributes to the CMC compound development with high level of autonomy and accountability Leads dossier authoring activities for early and late-stage projects, and manages multiple complex projects with potentially accelerated priority Challenges status quo and identifies business improvement areas (products and processes) and leads implementation of improvements Interfaces directly with internal and external functional stakeholders, including CMC team members, Regulatory, JSC (supply chain), and external service providers. Combines technical expertise with management skills. Provides oversight to external consultants and coaches project teams and/or more junior individuals within the organization Appropriately identifies and manages key stakeholders and escalates when needed to obtain senior management support. With limited guidance, takes day-to-day decisions on operational priorities for his/her projects Qualifications Education & Experience PhD with Post-doc experience with 6+ years relevant experience OR University degree with 8+ years relevant experience OR Equivalent by experience 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. What’s in it for you…? “Caring for the world, one person at a time…” As an employee we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2105964849W