Regulatory Affairs Head

hace 5 días

Mexico City Johnson & Johnson Innovative Medicine A tiempo completo

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. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category People Leader All Job Posting Locations Mexico City, Mexico Job Description About Innovative Medicine 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Purpose The Regulatory Affairs Head will manage the coordination, compilation and submission of new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies. At this level, the position has a greater degree of impact on the business results and responsibility for managing a group of professionals. You will be responsible for Leading and coordinating activities concerned with the submission and approval of products to government regulatory agencies. Providing guidance to project team members regarding regulatory compliance issues. Overseeing the preparation and maintenance of regulatory submissions and files. Establishing accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Ensuring adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products. Interacting with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters. Consulting with management personnel to establish and prepare appropriate regulatory filings for product approvals. Qualifications Minimum Education Required: Bachelor's degree. MBA is preferred. Experience Required: At least 8 years of experience. Regulatory Affairs experience. Experience leading teams. Experience Preferred: Expertise in business strategy, planning and execution. Experience in the healthcare sector. Ability to lead through influence and manage complexity. Effective communication and project management skills. Languages: Proficiency in English & Spanish is required. Travel: This position may require up to 10% of travel. #LI-Hybrid Required Skills No specific required skills listed. Preferred Skills Commercial Regulatory Developing Others Fact-Based Decision Making Inclusive Leadership Industry Analysis Innovation Leadership Legal Support Managing Managers Operations Management Policy Development Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Regulatory Requirements Regulatory Submissions Risk Compliance Strategic Thinking #J-18808-Ljbffr

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