Senior Regulatory Affairs Manager

Regulatory Affairs Expert with 8+ years of experience, specializing in rare diseases, geographic expansion, and European regulatory procedures

Successfully led regulatory submissions across 15+ countries and guided products through development and lifecycle management with a focus on efficiency and global alignment

Global regulatory strategy, dossier management, cross-functional collaboration, and project leadership

Directed regulatory strategy, tactical execution, and global submissions for assigned projects, with a focus on rare disease products

Led new application procedures in over 15 countries, including EU, Switzerland, South Korea, Australia, Mexico, Taiwan, and regions across the Middle East, ensuring alignment with regional regulatory requirements

Prepared and managed regulatory dossiers, including PIP submissions, scientific advice meetings, and orphan drug designations

Leading the creation and maintenance of the Company Core Data Sheet

Delivered regulatory intelligence, identifying and communicating emerging trends with potential business impact, fostering alignment with strategic goals

Acted as a key liaison between R&D, Franchise, and Commercial Operations to facilitate cross-functional collaboration on regulatory matters

Directed regulatory strategy, tactical execution, and global submissions for assigned projects, with a focus on rare disease products

Led new application procedures in EU, Switzerland, UK and Australia ensuring alignment with regional regulatory requirements

Contributed to US regulatory procedures, collaborating with the lead team to ensure alignment with FDA requirements and regulatory strategy

Prepared and managed regulatory dossiers, including PIP submissions, scientific advice meetings, and orphan drug designations

Leading the creation and maintenance of the Company Core Data Sheet

Acted as a key liaison between R&D, Franchise, and Commercial Operations to facilitate cross-functional collaboration on regulatory matters

Managed regional regulatory intelligence initiatives and contributed to global strategies for product compliance

Led regulatory activities for national procedures, overseeing Module 1 preparation and submission processes to ensure alignment with global regulatory strategies

Acted as the primary contact for health authorities in Austria, Germany, and Switzerland, managing authority requests and facilitating communication to support compliance and timely approvals

Represented the regulatory department in cross-functional teams, ensuring regulatory requirements were met throughout product lifecycle management as well as new application procedures

Collaborated with global teams to support market entry and maintenance activities, streamlining processes and aligning strategies with business objectives

Spearheaded the preparation, coordination, and submission of DCP/MRP and national regulatory procedures, ensuring compliance and timely responses to regulatory authorities

Conducted comprehensive deficiency management for new applications and lifecycle management

Assessed and implemented Change Control measures to maintain dossier compliance, particularly for Module 1 and Module 3-related changes

Coordinated with European national authorities, contract manufacturers, and internal teams, providing regulatory support and guidance to ensure successful submissions