Senior Manager Regulatory Affairs (f/m/d) 100%

Bachem is looking for a Senior Manager Regulatory Affairs with excellent communication skills and a business mindset to provide value-added input to internal stakeholders and clients. The role involves regulatory dossier writing, regulatory maintenance, and representation of Regulatory Affairs in internal and external stakeholder discussions and negotiations.

Requirements

• University degree Master and/or PhD with focus on natural sciences (Chemistry, Pharmacy, or similar field)
• Further training and certification in the relevant discipline
• At least 5 years of professional experience in regulatory affairs function
• Solid experience with the preparation, including technical writing, of Chemistry, Manufacturing and Control sections
• Solid experience with the registration requirements for Active Pharmaceutical Ingredients
• Solid experience of the regulatory requirements, dossier submission and life cycle management for Active Pharmaceutical Ingredients for global markets
• Solid experience in communication with customers and regulatory agencies
• Fluent and persuasive in French (C1) and English (C1) – German as a plus
• Experience in supervising complex projects and establishing regulatory strategies

Benefits

• Diversity in a dynamic environment
• Opportunity to work in an innovative environment and in a motivated team
• Modern terms of employment and attractive fringe benefits