Regulatory Affairs Specialist – Germany

Role Overview

We are looking for a dedicated and detail-focused Regulatory Affairs Specialist to join our team, focusing mainly on Germany but also engaging with other EU markets. This position involves ensuring regulatory compliance throughout all stages of the product lifecycle, starting from registration through post-approval maintenance.

Key Responsibilities

• Prepare, compile, and submit Marketing Authorisation Applications (MAAs) including new applications and variations for Germany and select EU countries.
• Support activities related to Orphan Drugs, line extensions, and product launches.
• Collaborate closely with project teams and clients to contribute to registration strategy development and timeline planning.
• Manage post-approval procedures such as variations, renewals, updates to product information (SmPC, PIL, labelling), and artwork reviews.
• Ensure that product documentation remains compliant with approvals throughout the product lifecycle.
• Stay updated with German national and European regulatory requirements and legislation.
• Adhere strictly to regulatory processes, country-specific regulations, and client procedures.
• Prepare for and support both internal and external audits, handling non-conformities and CAPAs efficiently.
• Serve as a primary contact with Health Authorities, maintaining professional and effective communication channels.
• Respond promptly to internal and client regulatory inquiries and assist cross-functional teams within a multi-client consultancy setting.
• Utilize regulatory and document management systems to prepare correspondence and submissions, track activities and timelines, and maintain documentation and databases.
• Frequently use tools such as Microsoft Office Suite, Veeva Vault or similar EDMS, LorenZ, TrackWise, and PromoMats.
• Ensure precise time and task tracking across assigned projects.

Qualifications & Experience

• A degree in a relevant life science subject such as Pharmacy, Biology, or Chemistry.
• Between 2 to 5 years of practical experience in Regulatory Affairs, particularly within the German regulatory environment.
• Comprehensive knowledge and involvement in product lifecycle management including new MAAs, variations, orphan drug management, line extensions, product information revisions, and artwork reviews.
• Previous professional interaction with Health Authorities.
• Experience in consultancy or managing multiple clients is beneficial.
• Strong IT skills and familiarity with digital tools.
• Strong organizational and communication abilities.
• A proactive work style, capable of both independent work and collaborating in teams.
• Demonstrated responsibility and ownership of assigned tasks.
• Competence in juggling various priorities in a dynamic workload.
• Background in promotional and non-promotional activities is considered a plus.
• Experience leading or mentoring others is advantageous.