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

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.