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

Triga Consulting; Leipzig; Híbrido; EUR 90 000 - 140 000; Tempo integral

Resumo da oferta

Triga Consulting is seeking a Regulatory Affairs Manager to support activities across Europe. The role combines strategic regulatory guidance with hands-on work on a varied portfolio and requires fluency in German (C1) and English, plus experience in GxP frameworks.

Location is remote with regular attendance at the Leipzig area office; occasional travel within Europe may be required. You will lead regulatory strategies, coordinate with cross-functional teams, and ensure compliant market access

Qualificações

• 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.

Responsabilidades

• 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 cross-functional 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 stakeholders.
• Prepare regulatory assessments and recommendations within demanding timelines.
• Support audits, inspections, authority requests, and related follow-up activities.
• Identify regulatory risks and opportunities and develop pragmatic compliance solutions.
• Deliver internal training and improve regulatory processes, standards, and awareness.

Conhecimentos

Regulatory affairs

European regulations

Regulatory strategy

GxP awareness

Stakeholder management

Formação académica

Relevant degree in life sciences

Descrição da oferta de emprego

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.