• Contribute to preparation and delivery of regulatory submissions • Preparation and review of Marketing Authorization Applications & Variations • Responsible for project planning and set-up • Ensures client expectations for quality and timeliness are met • Identifies new opportunities through Change in Scope or add-on business • Produces quality work that meets expectations of PC and the client • Supports development of business solutions addressing specific client needs

• Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance • Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements • Execute labeling operations globally with precision and efficiency • Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones • Prepare and review labelling documents for regulatory submissions and variations • Maintain labeling databases and tracking systems • Support global labelling harmonization initiatives • Collaborate with regional regulatory teams to ensure compliance with local requirements • Monitor regulatory intelligence related to labelling requirements

• Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance • Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements • Execute labeling operations globally with precision and efficiency • Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones • Prepare and review labelling documents for regulatory submissions and variations • Maintain labeling databases and tracking systems • Support global labelling harmonization initiatives • Collaborate with regional regulatory teams to ensure compliance with local requirements • Monitor regulatory intelligence related to labelling requirements

• Support the organization of security policies and documentation • Assist in identifying and tracking risks • Help collect evidence for audits • Provide support in preparing reports and controls • Assist initiatives related to LGPD and security best practices