Regional Regulatory Affairs Manager - EU/UK/CH

Role Overview

Join Merz Therapeutics as a Regional Regulatory Affairs Manager responsible for overseeing regulatory processes for the EU, UK, and Switzerland regions. You will be instrumental in guiding drug development, securing approvals, and managing the regulatory lifecycle while ensuring compliance with all applicable legal and regulatory requirements.

Key Duties

• Prepare and update comprehensive regulatory dossiers that align with EU/UK/CH standards and company policies.
• Coordinate submission of marketing authorization applications, new registrations, and GMP verifications according to local regulations.
• Implement regulatory changes at the local level and revise product information and packaging content as per national and company criteria.
• Manage product life-cycle regulatory activities including renewals, variations, and addressing post-approval obligations.
• Respond efficiently to regulatory authority deficiency notifications ensuring accuracy and timeliness.
• Serve as a liaison between regional and global teams, coordinate with local partners, and oversee collaborations with external service providers.
• Contribute to regional regulatory strategy development and maintain up-to-date knowledge of regional regulations and best practices.
• Prepare and participate in meetings with regulatory agencies, collaborating with both local and international stakeholders.

Candidate Profile

• Academic background in Pharmacy, Biology, Chemistry, or relevant scientific disciplines; doctoral degree preferred.
• 3 to 5 years of professional experience focused on regulatory affairs within EU/UK/CH, including familiarity with centralized procedures in pharma.
• Excellent communication skills, including intercultural competence and business-level English proficiency.
• Strong analytical and problem-solving abilities with effective teamwork and persistence.

Employee Benefits

• Career growth opportunities in a role contributing to improving patients’ quality of life.
• Hybrid working model supporting work-life balance.
• Convenient location with modern workplace facilities and company restaurant.
• Part of a global, family-owned firm promoting flat hierarchies and a respectful corporate culture.
• Competitive salary package coupled with comprehensive social benefits.
• Access to employer-supported benefits such as WellPass, Deutschland-Ticket, Corporate Discounts, and JobBike programs.

About Merz Therapeutics

Merz Therapeutics is a family-owned pharmaceutical leader focused on improving quality of life for patients dealing with movement disorders, neurological, and liver diseases among others. With over a century of heritage, we operate globally and offer innovative solutions across more than 90 countries. Our commitment to research ensures that unmet patient needs are addressed to achieve better treatment outcomes worldwide. Join our dedicated international team and help us deliver "BETTER OUTCOMES FOR MORE PATIENTS."