Global regulatory strategic platform – São Paulo/SP

Responsabilities

• Co-development of the regulatory strategy and provision of regulatory expertise within project/product teams for products under development and/or marketed products across Regions in scope (as per INN assignment) with focus to also find the synergies across the Regions in scope;
• Ensuring timely execution of the GRPS milestones for the development projects as per Blue print;
• Defining, coordinating and contributing to the preparation of the dossiers and responses documents  to Health Authority questions with the stakeholders (Non-clinical, clinical, Medical, Pharmacovigilance, etc.);
• Accountability for the maintenance of the existing CHC portfolio at the Regional level. As an interface between Science Innovation team/LCM team and countries will manage the preparation of ready to submit dossier for such activities as renewals, variations, benefit/risk assessments, referrals, discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, etc;
• Ensuring compliance of regulatory activities for development and marketed products across Region;
• Ensuring business continuity with the packaging management for shared packs (Standard Export Pack – SEP) implementation;
• Coordinating Regulatory sub-teams within Science Hub and be the regulatory representative in outside GRA    multi-function teams (in a e.g. strategic business reviews at Regional level, etc);
• Providing regulatory support for registration activities in countries outside of the Region in the spirit of Play to Win, searching for synchronization and synergies;
• Leading and coordinating scientific advices (including briefing package preparation), oral explanations       , pre-submission meetings for Regional projects/products;
• Following regulatory changes, competitor’s status and assessing potential impact on daily activities and  project strategy;
• Ensuring regulatory database and regulatory requirements are updated timely;
• Contributing as needed to review the opportunities from Business Development;
• High level coordination of Marketing Authorization transfers across of Regions in scope
  (legal aspect, regulatory assessment, requirements and planning).

Requirements

• Experience: 3-5 year experience in the CHC or pharmaceutical industry, in Regulatory Affairs (global, regional or local).
• Soft skills: leadership, resilience, strategic influence, stakeholder management, positive. Good relationship ability; Adaptation capabilities; Ability to think strategically and strive for results; Ability to make decisions; Ability to resolve issues and proactivity.
• Technical skills: Strong knowledge and operational expertise of Regional regulations, Ability to produce written and oral regulatory or scientific communications with clarity, accuracy, rigor and assertively, Ability to communicate effectively and efficiently with other functional departments in the business, Dealing with complex project involving multiple functions and resources.
• Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree.
• Languages: Fluent in English, Spanish, Portuguese

Marcado como: Assuntos Regulatórios, Indústria Farmacêutica