Regulatory Affairs Manager – Europe (m/w/d)

*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. **Contact:** Silvio Di Meglio 089-80913072-1 dimeglio@triga-consulting.de