Direct message the job poster from clinirxare you passionate about shaping the future of clinical research in latin america? Clinirx is looking for an experienced and driven regulatory affairs lead to guide our regulatory efforts across mexico, colombia, and other key regions such as argentina and costa rica.in this pivotal role, you’ll be leading and coordinating all regulatory activities for clinical studies from start to finish. Your mission: to ensure the successful approval and initiation of clinical trials by managing the strategy, development, and submission of clinical trial applications (ctas) to health authorities, ethics committees, and/or irbs in the region.as a proactive leader with strong communication and influencing skills, you’ll collaborate with cross-functional teams and provide expert guidance to meet quality standards, timelines, and budgetary goals. Reporting to our project director/director of project management, you’ll take ownership of regulatory strategies while ensuring strict compliance with clinical study requirements.we’re looking for someone who brings leadership, organization, and attention to detail to every project—someone who thrives in an independent role but values collaboration.if you're ready to make an impact in a dynamic and growing company, we’d love to hear from you.primary responsibilitiesdesign the regulatory submissions strategy for the assigned projects in alignment with the clients requirements and ensuring adherence to the project timelines.lead the regulatory and/or start up team on the preparation, submission and quality checks of regulatory documents for initial submissions, amendments and responses to request for information and or updates to regulatory authorities and ethics committees.ensure that the regulatory documentation is of quality by implementing processes and procedure enabling quality by design and a robust quality control on the generation of any final documentation before providing to clients and/or submission to the relevant competent authorities, irbs, ethics committees.leads the regulatory team discussions, proactively identifies risks and designs mitigation strategies.ensure the regulatory documentation is properly maintained, tracked and meets the relevant guidelines and standards while complying with the clients requirements.responsible for the development and maintenance of regulatory standard operating procedures (sops).leads regulatory intelligence activities, monitoring and analyzing regulatory changes and trends, providing insights to inform decision-making and regulatory strategies to ensure the organization stays updated on global regional regulations and guidelines.responsible for preparing and delivering regulatory activities training to other functions or clients as per needs.provide assistance in meetings with regulatory agencies and contribute to the resolution of regulatory queries.supervise a team of regulatory affairs professionals, fostering a culture of continuous learning and growth.mentor the more junior regulatory and start up team members.support in the preparation of proposals, study budgets and timelines and scope of work/service agreements/change orders, etc.qualifications and experiencebachelor's or master’s degree in life sciences or a related discipline.proven track record of successfully obtaining regulatory approvals for clinical studies and drug development us, canada, uk and europe.familiarity with the submission process in the clinical trials information system (ctis).experience with the design of the strategy for the development and submission of cta in other regions including us investigational new drug applications (ind) would be an advantage.thorough knowledge of regulatory procedures related to clinical trials and knowledge of relevant cross-functional dependencies.strong organizational skills with the ability to manage multiple tasks concurrently.detail-oriented, ensuring the accuracy and quality of regulatory documents.effective communication skills to collaborate with internal teams and regulatory authorities.experience in therapeutic areas like cns/neurology, oncology, cardiovascular and rare disease will be a great advantage.experience supporting business development with budgets, proposals and bid defense within cro environment.ability to adapt to a dynamic and evolving regulatory environment.proficient in microsoft office and other relevant software applications.seniority levelmid-senior levelemployment typefull-timejob functionwriting/editing, science, and otherindustriesbiotechnology research, pharmaceutical manufacturing, and research services
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