Key role in the implementation of a new Regulatory Information Management System and coaching of RA colleagues.
Identify areas for improvement within the Regulatory Affairs unit and at RA–stakeholder interfaces.
Initiate appropriate measures to drive innovation, modernization, and process improvements.
Hands-on authoring and review of regulatory documents from various backgrounds in accordance with applicable regulatory rules and guidelines.
Support RA colleagues on projects and progressively take on representation of RA in customer projects.
Coordinate responses to RA-related customer inquiries.
Coordinate responses to authority requests in close collaboration with our customers.
Provide regulatory advice to internal and external stakeholders.
Review documents and assess GMP changes from a regulatory perspective.
Manage internal and external stakeholders to achieve regulatory objectives while demonstrating a high degree of integrity, reliability, resilience, tenacity, openness and a collaborative spirit.

University degree (Master’s and/or PhD) in Natural Sciences (Chemistry, Pharmacy, or a related field).
Minimum of 2 years of professional experience in a Regulatory Affairs function.
Experience with Regulatory Information Management Systems (preferably Veeva).
Experience with migration and/or implementation of IT projects is a plus.
Strong communication and collaboration skills and a strategic mindset.
Ability to present scientific facts clearly and persuasively.
Committed, well-organized, and structured work approach.

Senior Specialist/Manager, Regulatory Affairs – 100%

Key skills