Regulatory Affairs Manager

Are you ready to leverage your regulatory expertise in a global setting?

The client offers an exciting opportunity as a Regulatory Affairs Manager at their site in Sempach, Switzerland. Join a dynamic team where you will manage worldwide marketing authorizations and provide regulatory support for a diverse range of products, including biocides and cosmetics.

Tasks & Responsibilities:

• Marketing Authorization: Manage worldwide marketing authorizations and provide regulatory support for biocides and cosmetics.
• Documentation: Create regulatory documentation (R4BP, PIF) for acquiring and maintaining registrations.
• Dossier Management: Handle variations to the dossier in accordance with the Change Control process.
• Authority Interaction: Prepare responses to requests by the Competent Authorities during the evaluation process and handle deficiency letters within a specific timeframe.
• Database Management: Create and maintain an up-to-date database and archiving system for tracking local regulatory dossiers in the region.
• Cross-functional Interaction: Communicate effectively and interact cross-functionally with all involved departments, both on regional and global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production, Medical Affairs, Marketing).
• Complaint Handling: Forward all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant person in Quality Assurance/Pharmacovigilance/Medical Affairs.
• Market Trends: Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market.

Professional Skills:

• Education: University education in natural sciences (pharmacy, chemistry, biology).
• Training: Further training in regulatory affairs (EU, CH, USA, Asia) is an advantage.
• Experience: Experience in the registration of biocides and cosmetics.
• Languages: Very good written and spoken English and German skills (additional language skills are beneficial).

Personal Skills:

• Analytical Thinking: Analytical and structured way of thinking and working.
• Organizational Skills: High organizational and communication skills.
• Interpersonal Skills: Good teamwork and interpersonal skills.

Benefits:

• Working Atmosphere: Open and pleasant working environment.
• Hierarchies: Flat hierarchies and efficient structures.
• Working Time Models: Interesting working time models.
• Development Opportunities: Various development opportunities.
• Health Promotion: Active health promotion by supporting external health offers.
• Family Support: Supporting families through the Family program.
• Employee Benefits: Various employee benefits, such as lunch and more.

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Interested? Contact us at or by phone at . We look forward to getting to know you!