Regulatory Affairs Manager

Regulatory Affairs Manager100% RemoteContractIntroduction / PurposeSupport registration of existing portfolio products in Switzerland and registration of development projects in this region. This role is key to driving both regulatory strategy and execution.Key Responsibilities / Scope of the JobIncluding, but not limited to, the following:Provide regulatory consulting for ODS applications, new marketing authorisation applications, as well as Swiss variations and PSUR submissions.Support a portfolio of products (subject to change based on the company portfolio).Prepare Swiss submissions based on applications submitted in the EU or other regions, including all documents required for Module 1 of the eCTD. Perform quality checks to ensure suitability for submission to Swissmedic (validation in line with Swissmedic requirements).Create and update Swiss Product Information (Information for Healthcare Professionals and Patient Information, as applicable) based on SmPC approved in the EU or other regions.Prepare Module 1 documents (forms and locally required documentation) based on company-provided materials (e.g. EU Module 1 submissions), including appropriate hyperlinking for Swissmedic purposes.Perform or support submission activities to Swissmedic via the appropriate electronic gateway and support the company throughout the full regulatory process.Establish and maintain contact with national regulatory authorities (Swissmedic).Provide advice on national regulatory affairs topics and country-specific requirements related to products.Advise on current Swissmedic requirements for packaging materials.Coordinate end-to-end local activities, including artwork coordination and proofreading.Education / ExperienceUniversity degree in Life Sciences with 8+ years of hands-on experience in Regulatory Affairs (registration, development, and maintenance).Experience leading projects and working with cross-functional teams.Personal AttributesStrong team player with the ability to work effectively across cultures, seniority levels, and functional areas.Highly self-motivated with the ability to drive activities independently.Excellent communication skills.Demonstrates strong values related to patient focus, collaboration, ownership, urgency, and integrity.Ensures exemplary ethical behaviour and transparency within the organisation and in interactions with regulatory authorities.