Senior Manager Regulatory CMC (m/w/d)

Pharma | Regulatory Affairs | CMC | Hamburg

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.

If you are interested in this challenging position, we look forward to receiving your detailed application quoting reference number 108 197 preferably via our ISG career portal ISG-Karriereportal or byr eMail.

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ISG Personalmanagement GmbH
Standort Hamburg
D-20354 Hamburg, Neuer Wall 80
Martin Kraml, T: +49 40 32849431
@: bewerbung.kraml@isg.com