Clinical/Regulatory Consultant

Title: Clinical / Regulatory Consultant
Location: Munich, Germany
Relocation: Supported - visa sponsorship available (Blue Card)

The Company
This is one of Europe's most respected regulatory consultancies, focused on high-level strategic input across global drug and device development. Over the past 20 years, they've supported more than 1,000 clients through complex regulatory and clinical challenges spanning all major therapeutic areas and drug modalities.

The firm is privately owned, growing steadily, and well known for its technical depth, collaborative team culture, and exceptionally high retention rate. Based in Munich with hybrid working options, they provide a serious, science-led environment where consultants are trusted to work autonomously and contribute meaningfully to high-impact development programs.

The Role
This is a strategic clinical/regulatory consulting position for someone who wants to help shape development programs, not just execute them. You'll work on complex and innovative projects involving small molecules, biologics, and ATMPs. The role involves designing global regulatory strategy, advising clients, leading regulatory interactions, and working closely with CMC, nonclinical, and commercial functions.

Responsibilities

• Lead clinical and regulatory development planning

• Develop global regulatory strategies from early phase to approval

• Advise cross-functional development teams and external clients

• Prepare and lead agency interactions and regulatory submissions (EU/US)

• Support projects involving advanced and emerging modalities (e.g., ATMPs, biologics)

• Collaborate with internal subject matter experts across CMC, nonclinical, and commercial areas

Candidate Profile

• Advanced degree (PhD, MD, or equivalent in life sciences)

• 10+ years of experience in pharmaceutical development

• Hands-on experience in clinical regulatory strategy (not just oversight or team management)

• Solid understanding of EU and US regulatory pathways

• Experience designing and executing global development plans

• Strong communication and stakeholder management skills

• Independent, strategic thinker comfortable in a client-facing environment