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Director Regulatory Affairs (f/m)

Bachem is a listed technology-based company focused 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. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

What are we looking for?
In this position you are accountable for the operative and personnel lead of the Regulatory Affairs (RA) department. You ensure the timely compilation of regulatory dossiers for our active pharmaceutical ingredients (APIs) as well as the sustainable filing of these dossiers with health authorities worldwide. Furthermore, you ensure regulatory compliance of APIs from company’s portfolio. As a regulatory affairs expert you collaborate with all internal and external stakeholders providing regulatory input to support decision-making.

 

What do we expect from you?
•    Master or PhD degree in chemistry, pharmacy or life sciences 
•    Minimum 8 years of experience in regulatory affairs, ideally both with drug substance (ASMF, US DMF, GDUFA DMF, CEP) and drug product submissions (MAA, NDA, ANDA, etc.)
•    Significant experience in leading regulatory teams
•    Good knowledge of registration requirements for human pharmaceuticals in the EU and US
•    Experiences with regulatory filing strategies, dossier content strategies and post-approval life-cycle management
•    Fluent in German and English
•    Independent, dedicated and initiative personality
•    Very good organizational and communication skills

 

Ideal candidate would bring experiences with registration requirements for peptidic APIs in international markets such as Japan, China, Brazil, Russia etc.

 

What can we offer you?
We offer an attractive position within a highly motivated and growing business unit of an internationally renowned company. You will have a comprehensive insight into all interdisciplinary aspects of our APIs along their life cycles rather than focusing on a few isolated topics of a few products only. Your dedication and contribution will make a difference.


Are you interested? Please submit your application with full supporting documents (motivation letter, CV, testimonials, diplomas) via recruiting tool to Mrs. Fabienne Carabelli (HR Business Partner)