Regulatory affairs analystmain responsibilities: support the execution of regulatory strategy.
implement the regulatory strategy for assigned products by processing registrations, renewals, post-approval changes, and promotional materials to obtain required health authorizations for business units.ensure complete regulatory submissions.
guarantee submission of complete dossiers to local health authorities through effective preparation and review processes to obtain timely approvals.maintain global data systems.
register product-related information in global electronic systems (veeva vault rim, qualipso, 4m promomats, onepack) to comply with sanofi's global guidelines.manage documentation and archives.
compile physical and electronic product dossier files by creating comprehensive backup documentation of all submissions to health authorities, ensuring compliance with corporate and regulatory requirements.manage stakeholder communications.
effectively communicate area requirements to internal and external clients (translators, notaries, vendors, and service providers) to obtain corresponding results and deliverables.regulatory intelligence support: update country cards and starr database for new registrations and modifications.foster cross-functional collaboration.
build effective collaborative networks with business partners (quality, pharmacovigilance, medical, institutional and private marketing, supply chain, market access, and public affairs) to ensure business continuity and objective achievement.continuous improvement: contribute to the development of standard operating procedures (sops) related to regulatory affairs.about you experience: entry positionlanguages: advanced english#li-lat #li-hybrid
pursue progress, discover extraordinary
better is out there.
better medications, better outcomes, better science.
but progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
so, let's be those people.
at sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
watch our all in video and check out our diversity equity and inclusion actions at pursue progress, discover extraordinarybetter is out there.
better medications, better outcomes, better science.
but progress doesn't happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
so, let's be those people.at sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.watch our all in video and check out our diversity equity and inclusion actions