Regulatory Affairs Manager – Europe (m/w/d)
Company: TRIGA Consulting GmbH & Co. KG - Internal
- Location: Leipzig, Germany
- Posted: Today
- Offer language: English
Job description
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
