Merz Therapeutics
Regional Regulatory Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Frankfurt am Main
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
OTOtsuka Pharma GmbH
Associate Director Global Regulatory Affairs(m/w/x)
Frankfurt am Main
ab USD 80.000 - 100.000 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory strategy for investigational and marketed pharmaceutical products. Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions required. Unlimited PTO, 401k matching.
Anforderungen
- Comprehensive knowledge of drug development process, laws, regulations, guidelines
- Good understanding of global regulatory agencies
- Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions
- University degree in Medicine, Pharmacy, Life Sciences, or Chemistry
- Several years of clinical/industry/health authority or relevant experience
- Good CMC knowledge
- Experience in Oncology, CNS, or Cardio-Renal therapeutic fields
- Strong information searching, summarization, and assessment skills
- Computer skills with Microsoft suite (Word, Excel, PowerPoint, Outlook)
- Strong analytical skills and problem-solving ability
- Strong communication and presentation skills
- Experience in cross-functional, multi-cultural project teams
- Strong knowledge and experience in European Regulatory Affairs
Aufgaben
- Provide global regulatory expertise for investigational and marketed products
- Ensure regulatory/competitive intelligence is provided
- Conduct scientific/regulatory information searching, summarization, and assessment
- Disseminate regulatory information to the organization
- Collaborate with Regulatory Management to establish clear regulatory pathways
- Create accurate and timely documents for submission and approval
- Provide strategic regulatory guidance
- Develop global regulatory strategy
- Plan and execute global investigational and marketed prescription drug submissions
- Manage lifecycle regulatory activities
- Serve as the primary contact to Competent Authorities in Europe and other regions
- Identify the need for and obtain regulatory intelligence
- Research precedent approvals and prior health authority decisions
- Assess applicability of regulatory intelligence to support strategic options
- Translate complex global requirements
- Assess associated regulatory challenges for stakeholders
- Lead cross-functional teams to develop global regulatory plans
- Address global regulatory issues
- Respond to health authority queries
- Meet regulatory obligations, focusing on European requirements
- Develop and lead strategy for health authority interactions
- Manage communications through submissions
- Respond to regulatory authorities within company timelines
- Review submission documents for alignment with strategic approach
- Design programs for complete and accurate IND/CTA/NDA/MAA submissions
- Ensure clinical trials meet regulatory requirements
- Support development of strategies for health authority submissions
- Draft responses for health authorities
- Review responses and documents for health authorities
- Ensure compliance with regulatory standards
- Review submission documents for consistency
- Interact with regulatory agencies
- Ensure regulatory agency conversations are focused and amicable
- Document regulatory agency communications
- Contribute to product registration submissions
- Submit progress reports, supplements, and amendments
- Submit aggregate and periodic adverse experience reports
- Collaborate with and oversee outsourced regulatory support suppliers
- Identify major regulatory issues early
- Communicate regulatory issues to relevant stakeholders promptly
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Otsuka Pharma 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.
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OTOtsuka Pharma GmbH
Associate Director Global Regulatory Affairs(m/w/x)
Frankfurt am Main
ab USD 80.000 - 100.000 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory strategy for investigational and marketed pharmaceutical products. Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions required. Unlimited PTO, 401k matching.
Anforderungen
- Comprehensive knowledge of drug development process, laws, regulations, guidelines
- Good understanding of global regulatory agencies
- Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions
- University degree in Medicine, Pharmacy, Life Sciences, or Chemistry
- Several years of clinical/industry/health authority or relevant experience
- Good CMC knowledge
- Experience in Oncology, CNS, or Cardio-Renal therapeutic fields
- Strong information searching, summarization, and assessment skills
- Computer skills with Microsoft suite (Word, Excel, PowerPoint, Outlook)
- Strong analytical skills and problem-solving ability
- Strong communication and presentation skills
- Experience in cross-functional, multi-cultural project teams
- Strong knowledge and experience in European Regulatory Affairs
Aufgaben
- Provide global regulatory expertise for investigational and marketed products
- Ensure regulatory/competitive intelligence is provided
- Conduct scientific/regulatory information searching, summarization, and assessment
- Disseminate regulatory information to the organization
- Collaborate with Regulatory Management to establish clear regulatory pathways
- Create accurate and timely documents for submission and approval
- Provide strategic regulatory guidance
- Develop global regulatory strategy
- Plan and execute global investigational and marketed prescription drug submissions
- Manage lifecycle regulatory activities
- Serve as the primary contact to Competent Authorities in Europe and other regions
- Identify the need for and obtain regulatory intelligence
- Research precedent approvals and prior health authority decisions
- Assess applicability of regulatory intelligence to support strategic options
- Translate complex global requirements
- Assess associated regulatory challenges for stakeholders
- Lead cross-functional teams to develop global regulatory plans
- Address global regulatory issues
- Respond to health authority queries
- Meet regulatory obligations, focusing on European requirements
- Develop and lead strategy for health authority interactions
- Manage communications through submissions
- Respond to regulatory authorities within company timelines
- Review submission documents for alignment with strategic approach
- Design programs for complete and accurate IND/CTA/NDA/MAA submissions
- Ensure clinical trials meet regulatory requirements
- Support development of strategies for health authority submissions
- Draft responses for health authorities
- Review responses and documents for health authorities
- Ensure compliance with regulatory standards
- Review submission documents for consistency
- Interact with regulatory agencies
- Ensure regulatory agency conversations are focused and amicable
- Document regulatory agency communications
- Contribute to product registration submissions
- Submit progress reports, supplements, and amendments
- Submit aggregate and periodic adverse experience reports
- Collaborate with and oversee outsourced regulatory support suppliers
- Identify major regulatory issues early
- Communicate regulatory issues to relevant stakeholders promptly
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Benefits
Gesundheits- & Fitnessangebote
- Health insurance
Betriebliche Altersvorsorge
- 401k matching
Mehr Urlaubstage
- Unlimited PTO
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Otsuka Pharma 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Otsuka Pharma GmbH
Branche
Pharmaceuticals
Beschreibung
Otsuka Pharma GmbH ist ein Unternehmen, das sich auf pharmazeutische Produkte spezialisiert hat.
Noch nicht perfekt?
- Merz Therapeutics
Regional Regulatory Affairs Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - Merz Therapeutics
Team Lead Regulatory Affairs Regions(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - Lilly Deutschland GmbH
Associate Director - Patient Safety and Regulatory Affairs(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBad Homburg vor der Höhe - IQVIA
Associate Director, Biostatistics - Global BIOS(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - 176 ICON Clinical Research Germany GmbH
Study Start Up Associate II(m/w/x)
VollzeitRemoteBerufserfahrenFrankfurt am Main