Title: Regulatory Project Management Consultant
Location: Munich, Germany
Relocation: Supported – visa sponsorship available (Blue Card)

The Company
This is one of Europe’s most respected regulatory consulting firms, known for delivering high-level strategic advice across drug and device development. Privately owned and organically grown over the past 20 years, they’ve supported over 1,000 clients worldwide with complex regulatory challenges. This is not an outsourced CRO model – they focus on quality-driven consulting underpinned by deep scientific expertise.

Their team is tight-knit, highly technical, and collaborative, with a 98% consultant retention rate and a strong reputation for excellence. Based in Munich, the company offers hybrid working and a culture that prioritises autonomy, integrity, and hands-on problem-solving.

The Role
This is a hands-on regulatory project management role focused on global submissions. You will lead planning and coordination from early-stage scientific advice through to full MAA, BLA, or NDA submissions. The role is client-facing and involves managing timelines, coordinating internal resources, and overseeing documentation across Modules 1–5. It’s ideal for someone who enjoys structure, precision, and owning delivery from end to end.

Responsibilities

• Lead full lifecycle management of EU and US regulatory projects

• Oversee submission content across Modules 1–5

• Manage project timelines, resources, and documentation workflows

• Act as the main point of contact with regulatory authorities and clients

• Coordinate and support scientific advice meetings

• Ensure regulatory compliance, quality, and on-time delivery

Candidate Profile

• Master’s or PhD in life sciences, medicine, or a related field

• At least 10 years of experience in regulatory affairs and project management

• Strong knowledge of FDA, ICH, and EU regulatory guidelines

• Demonstrated experience with agency interactions and lifecycle management

• Skilled with project planning tools (e.g., MS Project, Smartsheet)

• Fluent in English with clear communication skills

• Highly organised, detail-focused, and comfortable managing multiple complex submissions