Associate Director, Regional Regulatory Leader

Company: Disability Solutions
Location: Spring House
Posted on: September 19, 2023

Job Description:

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regional Regulatory Leader, supporting the Interventional Oncology R&D unit. The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor. The position can be located in Raritan, NJ; Spring House, PA; or within the United States or Canada (Eastern Coast preferred). Preferred location: Any Johnson & Johnson campus North America (other locations could be considered for the right candidate). 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 and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. Key Responsibilities:

• Responsible for developing and implementing US and/or regional strategy for assigned programs.
• Key contributor to the development and implementation of US and/or other regional regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
• In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
• Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
• Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
• Collaborate with cross-functional submission delivery teams.
• Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members through preparation of materials and meeting preparation.
• Serve as primary point-of-contact to Health Authority for assigned region(s).
• This role will include an opportunity to flex across different product types (pharma, devices, combo products).

Keywords: Disability Solutions, Philadelphia , Associate Director, Regional Regulatory Leader, Executive , Spring House, Pennsylvania