MANAGER, REGULATORY AFFAIRS

80.000.000 - 120.000.000


Join to apply for the Manager, Regulatory Affairs role at Johnson & Johnson Innovative Medicine . 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 https://www.jnj.com . Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category People Leader All Job Posting Locations: Bogotá Distrito Capital, Colombia Job Description The Regulatory Affairs Manager for the LA North region is responsible for regulatory science and crafting strategies to advance projects during early research stages, developing submissions, and obtaining approvals for initial marketing authorization applications and lifecycle management of assigned products. This role involves working closely with local, global, and cross-functional partners to ensure compliance and develop outstanding strategies for market assets. You Will Be Responsible For Performing the preparation, submission, and maintenance of filings. Collaborating with senior department members to expedite commercialization of new technologies, indications, and line extensions. Providing early inputs to identify barriers and needs to craft global development plans. Interpreting local and international requirements. Providing support to cross-functional teams and representing the company in interactions with authorities and industry associations. Collaborating with teams of varied strengths to ensure alignment and consistency in strategies and submissions. Playing a crucial role in making a significant impact on public health and contributing to the successful access of innovative therapies for the LA North population, within a team that values excellence, collaboration, and continuous learning. Qualifications - External Education Required: Licenciatura or Bachelor's degree Experience Required: At least 6 years of experience, with a strategic mindset and solid understanding of requirements and guidelines in the LA North region. Experience in leading submissions and interactions with regulatory authorities. Experience Preferred: Experience in regulatory affairs, preferably in the pharmaceutical or biotechnology industry. Ability to analyze information for effective scenario planning, leveraging strategies and opportunities for business growth. Capabilities to manage multiple projects simultaneously. Languages: Proficiency in English. Seniority level Not Applicable Employment type Full-time Job function Legal Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Johnson & Johnson Innovative Medicine by 2x. #J-18808-Ljbffr

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