Senior Manager, RA Submissions

<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 Product Submissions and Registration<p></p><p></p><p><b>Job Category:</b></p>People Leader<p></p><p></p><p><b>All Job Posting Locations:</b></p>Bucureşti, Romania, Leiden, Netherlands, Mechelen, Antwerp, Belgium, Warsaw, Masovian, Poland<p></p><p></p><p><b>Job Description:</b></p><p>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.</p><p>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at <a href="https://www.jnj.com/innovative-medicine" rel="noopener noreferrer" target="_blank"><span>https://www.jnj.com/innovative-medicine</span></a></p><p>We are seeking 3 Senior Managers, RA Submissions to be located in: USA (Raritan, NJ or Titusville, NJ) or EMEA (Turnhoustseweg, Belgium; Allschwil, Switzerland; High Wycomb, Great Britian; Leiden, Netherlands; Warsaw, Poland or Bucuresti, Romania)</p><p><b>Purpose:</b></p><p>The Senior Manager, RA Submissions is a member of the CTA Leadership team and provides direct supervision to the CTA team responsible for the delivery of compliant regulatory submissions required to support the development and registration of products. This position supervises CTA staff at global locations and at multiple levels and drives achievement of team results. This position may be responsible for performing additional project or submission related work based on area of responsibility. The Senior Manager, RA Submissions makes decisions that impact CTA submissions that will be viewed by external authorities. This position makes decisions on strategies within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges in the most efficient manner. The Senior Manager contributes to decisions on department guidelines, standards, processes, and resourcing. This position is charged with making decisions associated with the management of assigned personnel and local administration, including hiring and performance management. The Senior Manager, RA Submissions focuses on both short- and medium-term (1-2 years) needs of the department and their deliverables. This position may provide guidance to cross-functional teams about submissions strategy, processes, and timing. This position requires the ability to make decisions and resolve issues with limited supervision. The Senior Manager makes decisions for project and non-project staff assignments and resourcing. This position exercises independent judgment, and execution in anticipating, interpreting, evaluating and resolving complex organizational issues. This position keeps the supervisor apprised and solicits management support as needed.</p><p><b>The Senior Manager, RA Submissions must have knowledge of:</b></p><ul><li>Advanced knowledge of the product development process, CTA, regulatory affairs; knowledge of industry standards and trends, and internal submission requirements.</li><li>Knowledge of regulatory information management systems and tools.</li><li>Knowledge of global CTA regulations.</li><li>Effective therapeutic area and product knowledge.</li><li>Effective interpersonal, teamwork, and communication skills.</li><li>Knowledge of people management and leadership processes.</li><li>Ability to work or lead in a matrix environment.</li><li>Project management and submission management capabilities.</li><li>Skill in problem solving and troubleshooting.</li><li>Proficiency in submission related HA and Industry regulations and guidelines as relevant.</li></ul><p><b>You will be responsible for:</b></p><ul><li>Manages a team of CTA specialists in the planning and preparation and maintenance of regulatory submissions and filings. Provides guidance to project team members. Is responsible for performance oversight, development, and accountability of staff.</li><li>Manages and leads team in all HR processes including the 5 Conversations.</li><li>Leads the coaching and development process for team and other colleagues.</li><li>Leads others and holds staff accountable to the application of appropriate regulator