Für ein international erfolgreiches Pharmaunternehmen im Raum Mainz suchen wir zunächst befristet bis 28.02.2027 in Vollzeit und im Rahmen der ANÜ

In your global role reporting to the Head of Quality for CMC, Regulatory & PV, you work in close collaboration with RA CMC team and subject matter experts at the respective manufacturing sites or 3PQM Teams to provide the source CMC documentation for the Quality section ensuring state of the art documentation. You are responsible of the quality related CMC documentation for Life Cycle Management of existing global pharmaceutical products (i.e. tech documents required for variations, list of questions, geographical extensions and renewals). Thanks to your expertise, you will contribute to the continuous improvement of the AH Global Quality for CMC, Regulatory & PV department processes aligned with RA CMC processes and you will communicate them in the AH network.

Aufgaben:

•  As CMC Documentation Manager, you will bring your skills in CMC technical writing and you will prepare the respective quality CMC documentation in close collaboration with Reg. Affairs CMC, local CMC contacts or subject matter experts (e.g. Quality Control, production, etc.) at the respective manufacturing sites.
• Therefore, one of your key tasks will be the on-time delivery of documents and contents aligned with RA CMC processes and templates for existing global pharmaceutical products (i.e. tech documents required for variations, list of questions, geographical extensions and renewals).
• You will manage the requests and activity together with ad-hoc external support.

• Master degree (e.g. MBA, MSc) or equivalent with major focus on pharmaceutics, chemistry or other natural sciences
• Several years of industry experience with international exposure in daily business in either pharmaceutical development or production, chemical development, analytical sciences, quality control, quality assurance and/or regulatory affairs department, ideally in more than one of these areas with focus on regulatory affairs and scientific background
• Ability to work independently in international/multi-disciplinary project teams and to decide, prioritize and consolidate multiple tasks and complex issues
• Profound knowledge of worldwide GMP guidelines and preferably regulatory guidelines with regards to CMC
• Proven operational experience in preparation and review of analytical and manufacturing documentation regarding scientific issues
• Excellent English communication and interpersonal skills, combined with an autonomous, analytical and organized working style

Please submit your CV in both German and English to ensure your application can be considered!

Interessiert?

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