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Integrated Regulatory Outsourcing Pharmaceutical Physician Jobs Medical Communication Jobs

Regulatory Affairs CMC Manager
Location: Munich, Germany

My client, a global CRO company specialised in drug and device development, is looking for a Regulatory Affairs CMC Manager.


Job Description:
Prepare and write Investigational Medicinal Product Dossiers (IMPD), mostly in the CMC part;
Prepare and write Medicinal Product Dossiers (CTD/eCTD), in particular module 2.3 and 3;
Evaluate/perform gap-analysis of regulatory documentation (e.g., CTD/IMPD/IB);
Research scientific literature;

Prepare and manage scientific advice meetings on a national and European level;
Compile and submit clinical trial applications (EU);
Prepare and manage PIP applications;
Coordinate and manage clinical trial application procedures;
Compile and submit marketing authorization applications and follow-up submissions;
Coordinate and manage national, decentralized, and centralized marketing authorization procedures;
Review pertinent regulations to develop proactive solutions for regulatory issues and challenges; and
Interact with the national competent authorities, the EMA and ethics committees, and customers.

Your Qualifications:
Pharmacist or comparable degree in life science with or without Ph.D.;
At least 1-2 years experience in the pharmaceutical industry or CRO;
Experience in manufacturing and/or quality control of medicinal products preferred;
Willing to extend your professional knowledge in the area of pre-clinical and clinical development of medicinal products;
Excellent interpersonal skills;
Fluent English (written and spoken); and
Good knowledge of the MS Office applications.


You must be eligible to work in the EU

Key Words: Regulatory Affairs Manager CMC, Germany, Munich, Nürnberg, Relocatable

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