Senior Manager Regulatory CMC (m/w/d)

Permanent position · Full-time · Direct hire · Location: Hamburg

Our client is an internationally operating, fast-growing company in the pharmaceutical industry. For the Regulatory Affairs / CMC function, we are seeking an experienced Senior Manager (f/m/d), ideally with leadership experience, who will take end-to-end responsibility for regulatory activities in Europe and the United States and guide projects through all development phases with strong strategic vision.

What to Expect

• Permanent position in a future-proof pharmaceutical company
• Key role within an interdisciplinary project team with global exposure
• Real scope to shape regulatory strategies (EU & US)
• Potential mentor role for a small CMC team
• Flexible working hours and home-office options (partial remote possible)
• Attractive compensation package and professional development opportunities

Your Responsibilities

• Overall responsibility for regulatory CMC topics across EU & US
• Development and execution of approval strategies (incl. Scientific Advice procedures)
• Authoring and overseeing regulatory submissions (Modules 2–5)
• Communication with authorities, partners, and internal stakeholders
• Strategic project support from development to market authorization
• Assessment of regulatory requirements for due diligence and licensing projects

Your Profile

• Degree in natural sciences, pharmacy, or a comparable field
• At least 5 years of experience in Regulatory Affairs (EU & US – must-have)
• Deep knowledge of CMC, pharmaceutical technology, and international standards
• Strategic and solution-oriented mindset; strong communication and negotiation skills
• Proven experience in authoring and reviewing dossiers
• Fluent English; German is a plus but not required

Location & Ways of Working

The role is based in Hamburg . Remote work is possible (typically 2 days per week). During onboarding, on-site presence of approximately 3 days per week is expected. Long term, a regular on-site presence should be ensured.

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