Senior Manager Regulatory CMC (m/w/d)

ISG Personalmanagement GmbH

Hamburg - Deutschland

Regulatory-Affairs-Manager/in Arbeit Vollzeit ab 30.09.2025

Beschreibung

# Senior Manager Regulatory CMC (m/w/d)

## Pharma | Regulatory Affairs | CMC | Hamburg

[BEWERBEN](https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=108570&refererId=20)

**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 **108 570** preferably via our ISG career portal [ISG-Karriereportal](https://www.isg.com/jobs/applications/applyForJobEntry.jsf?inseratnummer=108570&refererId=20) or byr eMail.

Visit us at [isg.com/jobs](https://www.isg.com/jobs/search) - new job offers are posted daily.

ISG Personalmanagement GmbH
Standort Hamburg
D-20354 Hamburg, Neuer Wall 80
Martin Kraml, T: +49 40 32849431
@: [bewerbung.kraml@isg.com](https://mailto:bewerbung.kraml@isg.com)

Quelle: Bundesagentur für Arbeit - Rechtliche Hinweise zur Nutzung
Ob die Stelle noch verfügbar ist und weitere Informationen findest du direkt auf der Website der Bundesagentur für Arbeit. Bitte beachte: OPROMA ist nicht der Anbieter dieser Stelle und kann keine Auskünfte geben.