Remote + Leipzig: Regulatory Affairs Manager - Europe (m/w/d) - Pharma

An international pharmaceutical company is seeking an experienced Regulatory Affairs Manager to support its activities across Europe. The role combines strategic guidance with hands-on regulatory work across a varied portfolio of products and services. Regulatory Affairs Manager – Europe (m/w/d) Location: Remote, with regular attendance at the office in the greater Leipzig area The tasks: *Develop regulatory strategies for European markets and support compliant market access. *Assess regulatory requirements for products and services entering Europe from international markets. *Guide product launches, registrations, variations, and lifecycle activities across relevant jurisdictions. *Interpret evolving legislation and translate requirements into practical business actions. *Advise commercial, quality, and operational teams on regulatory questions throughout product lifecycles. *Coordinate with international regulatory colleagues to align regional approaches and share expertise. *Engage with authorities, notified bodies, external consultants, and other relevant partners. *Prepare regulatory assessments and recommendations within demanding business timelines. *Support audits, inspections, authority requests, and related follow-up activities. *Identify regulatory risks and opportunities, then develop pragmatic compliance solutions. *Deliver internal training and improve regulatory processes, standards, and awareness. Your profile: *You hold a relevant degree and have substantial experience in Regulatory Affairs. *You understand European regulatory frameworks, product lifecycle requirements, and quality expectations such as GMP and GDP. *You are comfortable owning complex topics, setting priorities, and explaining regulatory matters clearly. *You communicate fluently in German (C1) and English and build productive relationships across functions. The offer: The position offers an attractive compensation package, well-being support, and a collaborative working environment with direct communication and room to contribute Where you work: You may work remotely, with regular attendance at the office in Saxony. You can also travel to in-person meetings when required by authorities or other stakeholders.