Experienced RA Professional Lifecycle Submissions EM

Job description

At Johnson & 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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Product Submissions and Registration Job Category: Professional All Job Posting Locations: Istanbul, Turkey, Warsaw, Masovian, Poland Job Description: Cross-Regional Operations & Strategic Support (C-ROSS) is a regional capability driven Regulatory Affairs organization working in close collaboration with Local Operation Companies (LOC), regional and global teams. The responsibility of C-ROSS Lifecycle Submissions is to coordinate lifecycle management procedures in-scope from end to end, ensuring timely submission, implementation of the change in the applicable databases and, if applicable, artwork. • Established and productive individual contributor, who works under moderate supervision. • Helps establish and implement cost effective, results based, and professionally managed programs and innovative initiatives for the business area, under general supervision. • Contributes to components of projects, programs, or processes for the business area. • Conducts routine risk assessments and establishes processes to mitigate those risks under limited supervision within the business function. • Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. • Perform lifecycle management activities per established processes and country-specific requirements for Turkey and other Emerging market countries . o Propose strategy and timeline for National Procedure (NP) to the LOC. Liaise with Regional Regulatory Responsible (RRR) on strategies and timelines where applicable. o Prepare submission-ready documents/dossier(s) and ensure timely submission of high-quality (response) dossier. o Process Health Authority (HA) approvals to initiate post-approval activities promptly. • Ensure timely update of databases throughout lifecycle management. • Involve C-ROSS colleagues and external stakeholders at appropriate process steps. • Proactively monitor from end-to-end perspective regarding timely completion of lifecycle management activities and escalate issues. • Actively engage in internal process improvement initiatives and contributing to the implementation of new regional/local requirements, tools, and systems. Turkish language is a must Turkish regulation experience is a must Required Skills: Preferred Skills: