Director -Global Regulatory Leader, GRA Oncology

<p><span>At Johnson &amp; Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com</span></p><p></p><p></p><p><b><span><span>Job Function: </span></span></b></p>Regulatory Affairs Group<p></p><p></p><p><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Regulatory Affairs<p></p><p></p><p><b>Job Category:</b></p>Professional<p></p><p></p><p><b>All Job Posting Locations:</b></p>Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Leiden, Netherlands, Schaffhausen, Switzerland<p></p><p></p><p><b>Job Description:</b></p><p><span><b><span>About Innovative Medicine </span></b></span></p><p><span><span>Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.</span></span></p><p><span><span>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</span></span></p><p><span><span>Learn more at <span><span>https://www.jnj.com/innovative-medicine</span></span></span></span></p><p></p><p>Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):</p><p></p><p>United States - Requisition Number: <b>R-019817<span> </span></b><br/>United Kingdom - Requisition Number <b>R-019524</b></p><p></p><p>Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.</p><p></p><p><span><span>Remote work options may be considered on a case-by-case basis and if approved by the Company.</span></span></p><p></p><p><b>We are searching for the best talent fo</b><b>r Director, Global Regulatory Leader </b><b>to be in the United States, United Kingdom, Belgium, Switzerland or the Netherlands. </b></p><p></p><p><b><span>Purpose: </span></b> The Director, Global Regulatory Leader, is responsible for global regulatory strategies for select projects spanning the oncology therapeutic area.</p><p></p><p><b><span>You will be responsible for</span></b><b>:</b></p><ul><li><p>Responsible for the development, implementation, and maintenance of robust Global regulatory strategies. Applies expert analysis and interpretation of scientific data in assessing risk and in the creation of regulatory strategies to expedite new product introductions to the market.</p></li><li><p>Lead the Global Regulatory Team and be a key contributor on multiple cross-functional teams such as Compound Development Team (CDT) to ensure timely commercialization of new and modified products into key markets.</p></li><li><p>Provide strategic direction to the teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications.</p></li><li><p>Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs as assigned).</p></li><li><p>In interacting with the Health Authorities, the individual will lead and/or participate in meetings with Global Health Authorities (HAs) as appropriate.</p></li><li><p>Ensure business compliance, support due diligence activities, implement drug development strategies, and adhere to regulatory standards. Achieves compliance with regulatory agency regulations by providing expert counsel to enable products that are developed, manufactured, or distributed to meet required legislation.</p></li><li><p>Proactively creates a purpose driven environment by aligning Johnson &amp; Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.</p></li></ul><p></p><p><b>In GRL role leading the Global Regulatory Team <span><span>(GRT):           </span></span> </b></p><ul><li><p>Serve as a member of Labeling Working Group (LWG) to build or update the Company Core Data Sheet (CCDS) and for the target label contributes to the development of local labels as appropriate.</p></li><li><p>Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs.</p></li><li><p>Provide integrat