As a Regulatory Affairs Specialist at Queisser Pharma GmbH & Co. KG, you will play a crucial role in ensuring compliance with regulatory standards in the pharmaceutical industry. Your expertise will be essential in navigating the complexities of drug approval processes.

• Regulatory Consultation: Provide expert advice on approval projects, focusing on generic medications that require pharmacy prescriptions.
• Document Evaluation: Assess regulatory documents with an emphasis on quality documentation (CMC), including conducting thorough due diligence.
• Submission Management: Oversee and facilitate European approval procedures, including national, MRP, and DCP submissions.
• Change Notifications: Prepare and manage notifications for changes and extensions related to product approvals.
• Dossier Management: Handle approval dossiers with a focus on CMC and administrative application documents (Module 1).
• Regulatory Compliance: Implement new regulatory requirements from the EMA, including digitalization processes and revisions to EU pharmaceutical legislation.
• Product Information: Create and maintain product information texts, as well as evaluate marketing texts and promotional materials in accordance with legal standards.
• Project Coordination: Manage projects and maintain communication with regulatory authorities, service providers, and business partners.

This position offers an opportunity to contribute significantly to the regulatory landscape of pharmaceuticals, ensuring that our products meet the highest standards of safety and efficacy.