Regulatory Affairs Specialist

Johnson & Johnson is a global leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases. The company specializes in Innovative Medicine and MedTech, aiming to deliver breakthroughs that profoundly impact health for humanity. The Regulatory Affairs Specialist role is based in Schaffhausen, Switzerland, and involves providing regulatory support to the manufacturing site, ensuring compliance with Swiss and international regulatory requirements. This position is crucial for maintaining compliance and continuity of supply, acting as a key point of contact for regulatory activities. The main day-to-day responsibilities of the Regulatory Affairs Specialist include acting as the primary contact for site-related regulatory activities, preparing and managing regulatory documentation, and coordinating with health authorities. This involves preparing and submitting Swissmedic Major Change Notifications, managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, and Manufacturing Licenses. The role also includes responding to regulatory requests, supporting regulatory assessments, and participating in strategic site projects. Additionally, the specialist will provide regulatory guidance, improve regulatory awareness, and contribute to initiatives that enhance regulatory compliance and efficiency. To qualify for this role, candidates must have a Bachelor's or Master's degree in a relevant scientific field such as Pharmacy, Chemistry, Biology, Engineering, or Life Sciences. A minimum of four years of experience in the pharmaceutical industry within Regulatory Affairs, Quality, Compliance, Manufacturing, or another GMP-regulated environment is required. Strong organizational skills, the ability to manage multiple priorities, and a compliance-focused approach are essential. Fluency in both English and German, both written and spoken, is a must. Nice-to-have skills include experience interacting directly with Health Authorities, preferably Swissmedic, and managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, and Manufacturing Licenses. Experience supporting Change Control processes and regulatory impact assessments is also beneficial. The role offers a collaborative work environment and the opportunity to work on initiatives that strengthen regulatory compliance and efficiency. What the role asks for: - Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Engineering, Life Sciences, or another relevant scientific field - Minimum 4 years of experience in the pharmaceutical industry within Regulatory Affairs, Quality, Compliance, Manufacturing, or another GMP-regulated environment - Fluency in English and German, both written and spoken - Strong organizational skills with the ability to manage multiple priorities and deadlines - Strong stakeholder engagement and cross-functional collaboration skills - Ability to work independently while maintaining a compliance-focused approach - Strong communication and interpersonal skills - High attention to detail and quality mentality - Nice-to-have: Experience interacting directly with Health Authorities, preferably Swissmedic - Nice-to-have: Experience managing Certificates of Pharmaceutical Product (CPPs), GMP Certificates, Manufacturing Licenses, or regulatory authority requests - Nice-to-have: Experience supporting Change Control processes and regulatory impact assessments