Maria Joao Oliveira Email & Phone Number

Lisbon, Portugal

Portugal

Strategy and planning of artwork packaging activities for new business integrations. Optimization of end to end artwork related processes.

Portugal

Quality leader for medicinal products and medical devices, responsible for: 🔹Oversight of the quality system and service providers🔹Management of quality issues, inspections, audits and corrective actions🔹Promotion of continuous improvement initiatives. Main Achievements🔸 Change in third-party logistics leading to higher quality and customer satisfaction 🔸 Redesign of cold chain system for optimized transport aligned with customer needs🔸 Shortage prevention plans that avoided customer-level stock outs during Covid-19 pandemic

Portugal

Leader of the Regulatory Affairs department, responsible for: 🔹Spearhead regulatory strategies to introduce innovative medical products to the market🔹Oversight of marketing authorization and clinical trial applications for a portfolio of 50 products🔹Primary liaison with Regulatory Authorities, fostering effective collaboration and communication 🔹Strategic regulatory guidance to cross-functional teams throughout the products lifecycle🔹Assess the impact of the framework changes and industry trends on the portfolio and business strategies.Main Achievements🔸Successful regulatory approvals in diverse therapeutic areas, including oncology, hematology, rheumatology, neurosciences and rare diseases🔸Pre-approval engagements with the Regulatory Authorities resulting in optimized development plans and accelerated regulatory approvals 🔸Horizon scanning portfolio meetings with the Regulatory Authorities, contributing to productive collaboration.

Portugal

Lead and develop team members, acting as a catalyst and coach and fostering a culture of empowerment, growth and excellence. Main Achievements🔸Led up to 11 direct reports, including people leaders, with excellent performances and outcomes🔸Successfully led cross-functional teams achieving project milestones within specified timelines and budgets

Portugal

Responsible for the implementation of local compliance model, aligning business priorities with sustainable compliance practices. Provide guidance and oversight to ensure adherence to industry standards and ethical practices across all organization.Main Achievement🔸Design and implementation of a robust disclosure system that annually publishes hundreds of stakeholder engagements.

Philadelphia, Pennsylvania, United States

Regulatory liaison for gene therapy development initiatives in ex-US markets, navigating complex regulatory frameworks. Main Achievements🔸Engagements with the Regulatory Authorities that informed product development plans and regulatory strategy.

Basel

Contributor to EU regulatory initiatives, including pediatric investigation plans, orphan drug applications, and engagement with the European Medicines Agency

Portugal

Local Safety Responsible and driver of compliance with good pharmacovigilance practices

Portugal

Portugal

Portugal

Pos Graduation, Regulatory Affairs

Pos Graduation, Health Economics

Degree, Pharmacy