Interact with key stakeholders and perform activities related to dossier submission (paper and/or electronic) for innovative products. Familiarize themselves with the latest changes in BoH legislation.
• Possess a thorough understanding of the Cluster market requirements, as well as the regulatory processes.
• Work closely with the LatAm Regional Hub to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated.
• Routinely monitor Health Agency’s website for information related to product registration, line extensions and post-approval changes. Understand local regulations and trends.
• Keep current with the BoH legislation, as well as update the regulatory information on Pfizer intranet as applicable.
• Complete departmental training in a timely manner to address corporate and regulatory needs.
• As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.