Director Regulatory Affairs (m/w/d) - greater Basel area

Is strong team spirit very important to you? Are you an enthusiastic natural scientist and have a fable for meticulous and super-precise work? Your fingers tingle when you hear the word drug approval? Can you identify yourself 100% with a role as an internal consultant for regulatory issues? If you feel like experiencing this at an international pharmaceutical company in Switzerland, working on a global scale and holding a leading position in the field of peptides, then you've come to the right place!

What are your tasks as Director Regulatory Affairs?

• Accountable for the operative and personnel lead of the Regulatory Affairs department
• Ensure the timely compilation of regulatory dossiers for active pharmaceutical ingedients (APIs)
• Ensure the sustainable filing of dossiers with health authorities worldwide
• Ensure Regulatory Compliance of APIs from the company's portfolio
• Collaboration with all internal and external stakeholders providing regulatory input to support decision-making

Which requirements are needed for the Director Regulatory Affairs?

• D. or master's degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable
• At least eight years in a scientific/technical CMC development or regulatory affairs function, ideally with experience in both drug substance (ASMF, DMF etc) and drug product submissions (MAA, NDA etc.)
• Significant experience in leading regulatory teams
• Very good knowledge of registration requirements for human pharmaceuticals in the EU & US
• Very good knowledge with regulatory filing strategies, dossier content strategies and post-approval life-cycle management
• Fluency in Germany and English, both written and spoken
• Strong organizational and communication skills

What can you expect as Director Regulatory Affairs?

• Highly motivated and massively growing business unit of an internationally renowned company
• Insight into all interdisciplinary aspects of their APIs along their life cycles rather than focusing on a few isolated topics

About the client?

Our client is a listed technology-based company focusing on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. Headquartered in Switzerland, the company has subsidiaries in Europe, the US and Asia. With their close to 50 years experience in peptide research, they can provide excellent know-how in peptide chemistry and organic synthesis and efficient manufacturing processes.

Contact for application:

• E-Mail: gotzler@sciproglobal.de
• Tel: +49 (0)89 / 21 09 49 06
• Xing: https://www.xing.com/profile/Sebastian_Gotzler/portfolio?sc_o=mxb_p
• LinkedIn: https://www.linkedin.com/in/sebastian-gotzler-39617a15a/