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.