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

Triga Consulting GmbH & Co KG; Berlin; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Well-being support

Direct communication

Job summary

International Pharmaceutical Company seeks an experienced Regulatory Affairs Manager to guide European regulatory strategy and hands-on regulatory work across a diverse product portfolio. The role requires ownership of complex topics, priority setting, and clear regulatory communication.

You will collaborate with commercial, quality, and operations teams, engage with authorities and external partners, and support lifecycle activities across Europe.

Qualifications

• You hold a relevant degree and have substantial experience in Regulatory Affairs.
• Understand European regulatory frameworks, product lifecycle requirements, and quality expectations such as GMP and GDP.
• Communicate fluently in German (C1) and English 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 expertise

Regulatory strategy

Cross-functional collaboration

German language

English language

Education

Regulatory Affairs degree

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.