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

Triga Consulting GmbH & Co. KG; Berlin; Remote; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Well-being support

Job summary

An international pharmaceutical company seeks an experienced Regulatory Affairs Manager to support activities across Europe. The role blends strategic guidance with hands-on regulatory work for a diverse product portfolio.

Location is remote with regular attendance at the office in the greater Leipzig area; travel to Saxony and in-person meetings may be required. The position emphasizes fluency in German (C1) and English, and collaboration across functions.

Qualifications

• Substantial experience in Regulatory Affairs.
• Understanding of European regulatory frameworks and lifecycle requirements.
• German (C1) and English proficiency and ability to communicate across functions.

Responsibilities

• 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.

Skills

Regulatory affairs

European regulatory frameworks

GMP & GDP knowledge

German/English fluency

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.