Become a Catalyst for Global Healthcare Innovation as Our Regulatory Affairs Manager, Global Labelling
Are you ready to make a real difference in the world of healthcare by leading innovative global labelling strategies? Join us in this pivotal role where your expertise will directly impact patient access to vital medicines, ensuring compliance and clarity across diverse markets. Be part of a forward-thinking team dedicated to transforming healthcare through precision and regulatory excellence.
Overview As our Regulatory Affairs Manager, Global Labelling, you will oversee and shape the global labelling strategies for biosimilars and other critical pharmaceuticals. This role offers the opportunity to work remotely, primarily from Austria, with some flexibility to attend the Kundl office. You will collaborate across regions to streamline labelling processes, manage regulatory documentation, and ensure adherence to EU and US regulatory standards.
Key Responsibilities
Lead global labelling activities, ensuring accurate, compliant, and market-specific product labelling for biosimilars in EU and US markets.
Manage regulatory documentation and submissions, maintaining alignment with project timelines and regulatory requirements.
Oversee and optimize labelling processes within Veeva platform systems, including Regulatory Management and Document Management.
Coordinate with cross-functional teams to deliver consistent and compliant labelling content.
Stay current with evolving regulations and guidance to proactively adapt labelling strategies.
Support audit and inspection readiness related to labelling processes.
Ensure all labelling activities meet quality, compliance, and business needs.
Must-Have Qualifications
Proven experience in Global Regulatory Labelling, especially within EU (Centralized Procedure for Biosimilars) and US (BLA).
Hands-on experience with Veeva platform (Regulatory Management System & Document Management System).
Ability to navigate complex regulatory environments, ensuring compliance across multiple regions.
Strong coordination and communication skills to work effectively with global teams.
Nice-to-Have Skills
Experience working within the biosimilar or pharmaceutical industry.
Familiarity with remote working setups and digital collaboration tools.
Knowledge of international regulatory frameworks beyond EU and US.
This role offers flexible working and the chance to influence global healthcare products from the comfort of your home office.
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Regulatory Affairs Manager, Global Labelling in Wien Arbeitgeber: Planet Pharma
Planet Pharma ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, in einem dynamischen und unterstützenden Umfeld zu arbeiten. Mit einem starken Fokus auf Mitarbeiterentwicklung und einer internationalen Präsenz ermöglicht das Unternehmen seinen Freelance Clinical Research Nurses, wertvolle Erfahrungen in der klinischen Forschung zu sammeln und gleichzeitig flexible Arbeitsbedingungen zu genießen. Die Unternehmenskultur fördert Vielfalt und Inklusion, was Planet Pharma zu einem attraktiven Arbeitsplatz für alle qualifizierten Fachkräfte macht.
