Regulatory Affairs Lead (m/f/d) unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries. Our client is a well-established Swiss company with a strong track record as an innovative and reliable partner within the life sciences sector. On behalf of our client, we are currently looking for a: Regulatory Affairs Lead (m/f/d) Location: Basel Metropolitan Area Position In this role, you will take a key position in the further development and strategic strengthening of the Regulatory Affairs function. You will combine hands-on regulatory work with strategic oversight and ensure that regulatory requirements across multiple product categories are managed efficiently and proactively. Working closely with internal stakeholders, external partners and international health authorities, you will contribute significantly to maintaining regulatory compliance while supporting the company’s product development and global business activities. Tasks Development and continuous improvement of the global Regulatory Affairs strategy with a focus on pharmaceutical APIs Regulatory oversight of relevant dossiers and documentation, including Drug Master Files (DMFs), ASMFs, CEPs and technical documentation Interaction with health authorities and coordination of regulatory responses and submissions Responsibility for labeling governance and regulatory claims across different product categories Providing regulatory input for new product development projects and product lifecycle management Selection, coordination and management of external regulatory consultants Contribution to the development and improvement of internal r