Senior Expert Global Regulatory Affairs Biologicals
The Position In this role, you will be accountable for defining worldwide regulatory strategies and requirements for biological projects with a strong focus on established vaccines. You will shape the content of regulatory filings for biological products and coordinate agency submissions as well as interactions with external outsourcing partners, where applicable. As part of the Global Regulatory Affairs organization, you will contribute your veterinary regulatory expertise to cross‑functional project teams and support the strategic direction of RA/PV. This position is part time eligible with 50%. Tasks & responsibilities In this role, you will define worldwide regulatory strategies and requirements for biological projects with a focus on established vaccines. Within your area of responsibility, you will define regulatory requirements and submission classifications for project activities. By defining robust submission packages, you will support agency filings aimed at obtaining approval within the best possible timeframe and with a high probability of success. As part of global project teams, you will actively participate in meetings, provide regular updates, and contribute to veterinary regulatory strategy. With your veterinary expertise, you will share knowledge and build regulatory understanding within the project teams. When required, you will review protocols and reports and write regulatory position papers or veterinary medicinal regulatory justifications for dossiers or exchanges with authorities. In addition, you will provide input to the strategic direction of Regulatory Affairs / Pharmacovigilance as a member of the Global RA teams.
Requirements
Advanced degree in Life Sciences (e.g. veterinary medicine, human medicine, PhD in pharmacy, biology) and / or degree in Life Sciences with relevant international experience You bring long term experience in Veterinary Regulatory Affairs with excellent knowledge of regulatory legislation and requirements for the worldwide development and maintenance of biological veterinary medicinal products. You have proven experience in veterinary medicine, particularly in vaccinology, across one or more key biological modalities. Acting as a key interface, you are experienced in direct interaction with Regulatory Authorities in primary countries and ensure the integrity of compliance with authority requirements. Within your scope of responsibility, you provide veterinary regulatory services to Global Innovation, Global Supply, and OPU/ROPUs. You are comfortable working in remote and internationally distributed teams. You are fluent in English; German language skills are considered a plus Ready to contact us? If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: [email protected] Recruitment process: Step 1: Online application - The job posting is presumably online until 23rd of June. We reserve the right to take the posting offline beforehand. Step 2: Virtual meeting until end of June Step 3: Panel interviews starting beginning of July Please submit your application documents in English.