Regulatory Affairs Specialist

An innovative pharmaceutical laboratory working in the pharmacy and biotechnology areas reinforces its team and is hiring a   Regulatory Affairs Specialist TRB Chemedica is a major international pharmaceutical company, headquartered in Switzerland, specializing in the manufacturing and distribution of innovative therapeutic solutions in ophthalmology, rheumatology and neurological diseases treatments. The group has been active in over 70 countries for over 40 years.   As a company that values close-knot collaboration, TRB Chemedica promotes a corporate culture where autonomy, trust and innovation drive professional growth. The head office in Geneva, Switzerland, oversees global marketing, commercial operations, global operations and new product development.   Your responsibilities: Be responsible for the registration, writing, coordination, implementation, execution, control and completion of product registrations. Provide regulatory support for registrations, maintenance and post-marketing activities: Prepare submissions for new product approvals. Prepare and maintain all required documentation for assigned products/projects. Create/review relevant documents, including change controls, manufacturing changes, instructions for use and product development reports. Manage the packaging materials workflow from the artwork to ready-to print, review and approve the packaging materials by delegation. Communicate with customers and health authorities to respond to regulatory concerns/questions. Provide regulatory intelligence and follow international legislation and guidelines to evaluate their impact on existing registration files. Work in close collaboration with R&D, pharmaco-materio vigilance, quality, production, supply, project management office, marketing and external partners. Develop and maintain regulatory procedures and dossiers to ensure ongoing compliance of existing and new products. Provide regulatory strategy input to project teams through the development of new products or lifecycle management activities. Develop TRB’s regulatory information and documentation system.   Your profile: Degree in Life Sciences (pharmaceutical, medical, healthcare) or related field. More than 8 years of experience in regulatory affairs within the pharmaceutical and/or medical device industry with a wide international scope. Medical device and drug experience essential – including relevant experience in new product development and strategic understanding of registration processes. Experience working with TÜV SÜD a strong plus. Solid experience in managing packaging components and packaging processes. Good knowledge of eCTD. Fluent in French and English (C1 level). Good written (technical writing required) and oral communication. attention to detail and highly organized. Teamwork personality, adaptable, multitasking and able to work with minimal supervision. Open-minded, proactive and solution-focused attitude.   Our Offer: We provide a dynamic, supportive, and engaging environment that fosters professional development, self-empowerment, and encourages initiative and autonomy. Join us to make an impactful contribution to global health. Please submit your complete application (CV, cover letter, and copies of work certificates and diplomas). Incomplete applications will not be considered. jid1b20caaafr jit0416afr