Regulatory Affairs Manager

Regulatory Affairs Manager m/f/d, Zürich This role supports regulatory activities for the development, registration, and life-cycle management of vaccine candidates across Europe. The position manages assigned regulatory projects, including preparation and maintenance of dossier and Marketing Authorization Application (MAA) submissions, ensuring all filings comply with regional requirements. It provides regulatory oversight for assigned clinical trials as well as non-clinical and clinical aspects of drug development and approval. Working closely with global and regional regulatory counterparts, the role helps ensure alignment and effective execution of the global regulatory strategy. The position collaborates with the RAV Europe Region Head and Lead, as well as local operating companies, to support strategy execution during submission preparation, review, approval, and post-approval activities. It is responsible for the content and timely availability of CTD Module 1 components and other local regulatory filings, including variations and labeling inputs. The role ensures compliance with internal processes and regional regulations, with a strong emphasis on quality and accuracy. Additionally, it supports the preparation of health-authority interactions and manages submission components and documentation within the Electronic Document Management System (EDMS). Contract Start Date: 02/03/2026 Contract End Date: 31/08/2026 Requires approximately 10 % travel. Responsibilities: Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe. Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region Ensures that all necessary applications are filed and maintained in compliance with applicable regulations. Responsible for regulatory oversight of assigned clinical trials conducted in the region. Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations. Collaborates with all Takeda regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects. Leads and directs the work of others as part of a matrixed organization. Close collaboration with the RAV Europe Region Head and Lead (and LOCs as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management. In cooperation with key stakeholders and RAV Europe Region Head/Lead (and LOCs as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Supports overall content and management of local regulatory components and filings e.g. MAA, MA variations. Contributes to content for local label development. Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication. Supports RAV Europe Region Head/Lead in the preparation of health authority interactions/meetings in the region as applicable for specified projects. Responsible for managing of submission components in the Electronic Document Management system (EDMS). Responsible for filing and archiving of regulatory relevant documentations/HA. Requirements: Bachelor's Degree preferred. A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 6 years regulatory and/or related experience in the vaccine area. Preferred experience in managing filings to EMA via Centralised Procedure resulting in first time approval; or managing multiple programs in closely related development area. Vaccines and/or biologics experience is essential. Participation in Global regulatory filing a plus Sounds like a great job? Then we look forward to receiving your complete application documents through our online application form. When applying by email, the sender agrees that his or her data will be used in accordance with our data privacy policy. Find more vacancies at: coopers.ch