Merz Therapeutics
Regional Regulatory Affairs Manager (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Frankfurt am Main
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Dein persönlicher KI-Karriere-Agent
MEMerz Aesthetics GmbH
Regulatory Affairs Manager Biologicals, Regulatory Affairs EU/ROW (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Developing regulatory strategies for biologicals in Asia-Pacific and EU/ROW markets. 2+ years of medicinal product regulatory affairs experience required. Company day care centers, flexible working hours, and mobile working.
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Anforderungen
- Degree in Pharmacy, Natural Sciences, or comparable qualification
- At least 2 years regulatory affairs experience with medicinal products (biologicals)
- Experience with Clinical Trial Applications in EU (EU Regulation 536/2014)
- Experience with registration of medicinal products in EU via Mutual Recognition Procedures
- Experience with CTIS submissions
- Experience with CTD compilation and filing
- Experience with document filing and archiving
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Experience with regulatory affairs for medicinal products in ROW markets
- Experience with APAC countries (China, Japan, South Korea)
- Experience with DocuBridge is advantageous
- Fluent English communication
- Business fluent German is advantageous
- Additional language skills, particularly Chinese or Japanese, are advantageous
- Creative mindset
- Innovative thinking
- Strong communication skills
- Emotional intelligence
- Resilience
- Problem-solving capabilities
- Highly organized
- Strong time management skills
- Strong prioritization skills
- Collaboration skills
- Project management skills
- Leadership skills
- Influencing skills
Aufgaben
- Develop and execute regulatory strategies for new product registrations
- Manage product lifecycle activities across EU and international markets
- Focus on regulatory strategies for the Asia-Pacific region
- Provide regulatory expertise to cross-functional project teams
- Ensure compliance with evolving regional regulatory requirements
- Prepare, coordinate, and submit Clinical Trial Applications (CTAs)
- Submit CTA amendments in accordance with EU CTR 536/2014
- Submit CTA amendments in accordance with international requirements
- Support compilation of regulatory dossiers for marketing authorizations
- Support maintenance of regulatory dossiers for marketing authorizations
- Support submission of regulatory dossiers for marketing authorizations
- Support compilation of regulatory dossiers for registrations
- Support maintenance of regulatory dossiers for registrations
- Support submission of regulatory dossiers for registrations
- Manage regulatory activities for new registrations
- Manage regulatory activities for approval procedures
- Manage regulatory activities for variations
- Manage regulatory activities for line extensions
- Manage regulatory activities for renewals
- Manage regulatory activities for post-approval commitments
- Contribute to creation of Company Core Data Sheets (CCDS)
- Contribute to maintenance of Company Core Data Sheets (CCDS)
- Contribute to implementation of Company Core Data Sheets (CCDS)
- Contribute to creation of product information documents
- Contribute to maintenance of product information documents
- Contribute to implementation of product information documents
- Coordinate responses to regulatory authority questions
- Prepare responses to regulatory authority questions
- Ensure timely and compliant submissions of responses
- Monitor global regulatory developments
- Assess impact of regulatory developments on products
- Assess impact of regulatory developments on development programs
- Prepare for interactions with health authorities
- Participate in interactions with health authorities
- Participate in scientific advice meetings
- Participate in consultations with health authorities
- Maintain regulatory databases
- Maintain submission tracking tools
- Maintain document management systems
- Collaborate with internal stakeholders to achieve regulatory objectives
- Collaborate with affiliates to achieve regulatory objectives
- Collaborate with partners to achieve regulatory objectives
- Collaborate with external consultants to achieve regulatory objectives
- Support inspections
- Support audits
- Support other regulatory compliance activities
Berufserfahrung
2 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Deutsch – verhandlungssicher
Japanisch – Grundkenntnisse
Englisch – fließend
Chinesisch – Grundkenntnisse
Tools & Technologien
Microsoft WordMicrosoft ExcelMicrosoft PowerPointDocuBridge
Benefits
Kinderbetreuung
- Company day care centers
Flexibles Arbeiten
- Flexible working time models
- Flex-working time
- Mobile working
Mehr Urlaubstage
- Generous annual leave
Mentoring & Coaching
- Regular development discussions
- Coaching sessions
Weiterbildungsangebote
- Management training courses
- Specialist training courses
- Soft skills courses
- E-learning courses
- Language courses
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Merz Aesthetics GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Merz Aesthetics GmbHÜber das Unternehmen
ME
PharmaceuticalsFrankfurt am Main
Das Unternehmen ist ein unabhängiges, international tätiges Unternehmen im Bereich der ästhetischen Medizin.
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