Our Development Team is guided by our purpose:
You bring regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset.
Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Biologics and Small Molecules projects/ products.
~ Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
~ Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
~ Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
~ Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
~ In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process.