Merz Therapeutics
Regional Regulatory Affairs Manager(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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OTOtsuka Pharma GmbH
Associate Director Global Regulatory Affairs(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global regulatory strategy development for investigational and marketed drugs. Comprehensive drug development, laws, and global regulations knowledge required. Document creation for submission and approval.
Requirements
- Comprehensive drug development process knowledge
- Comprehensive drug laws knowledge
- Comprehensive global regulations knowledge
- Comprehensive guidelines knowledge
- Good understanding of global regulatory agencies
- Leading CTA submission experience
- Leading IND submission experience
- Leading sNDA/NDA/MAA/Variations submission experience
- University degree in Medicine, Pharmacy, Life Sciences or Chemistry
- Several years clinical/industry/health authority experience
- Preferably global or European role experience
- Good CMC knowledge
- Experience in Oncology therapeutic field
- Experience in CNS therapeutic field
- Experience in Cardio-Renal therapeutic field
- Strong information searching skills
- Strong summarization skills
- Strong assessment skills
- Microsoft Word proficiency
- Microsoft Excel proficiency
- Microsoft PowerPoint proficiency
- Microsoft Outlook proficiency
- Strong analytical skills
- Problem solving ability
- Strong communication skills
- Strong presentation skills
- Excellent English language command
- Experience in cross-functional project teams
- Experience in multi-cultural project teams
- Communicating with cross-functional project teams
- Communicating with multi-cultural project teams
- Involving internal and external experts
- Strong knowledge in European Regulatory Affairs
- Experience in European Regulatory Affairs
- Strategic European Regulatory Affairs aspects
- Operational European Regulatory Affairs aspects
Tasks
- Provide global regulatory expertise for pre-clinical, clinical, and commercial areas
- Ensure regulatory and competitive intelligence is searched, summarized, and disseminated
- Collaborate with Regulatory Management to establish clear regulatory pathways
- Create accurate and timely documents for submission and final approval
- Develop global regulatory strategy and plan for investigational and marketed drugs
- Manage lifecycle regulatory activities in alignment with Therapeutic Area Lead
- Serve as primary contact to Competent Authorities in Europe and other regions
- Identify and obtain regulatory intelligence and precedent approvals
- Translate complex global requirements and assess regulatory challenges
- Lead cross-functional teams to develop global regulatory plans and address issues
- Respond to health authority queries and meet regulatory obligations
- Develop and lead strategy for Health Authority interactions and communications
- 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 and review responses for health authority submissions
- Review submission documents for consistency and strategic alignment
- Interact with regulatory agencies and document conversations
- Contribute to product registration, progress reports, and adverse experience reports
- Collaborate with outsourced suppliers for regulatory document preparation
- Identify and communicate major regulatory issues to stakeholders
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Otsuka Pharma GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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OTOtsuka Pharma GmbH
Associate Director Global Regulatory Affairs(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global regulatory strategy development for investigational and marketed drugs. Comprehensive drug development, laws, and global regulations knowledge required. Document creation for submission and approval.
Requirements
- Comprehensive drug development process knowledge
- Comprehensive drug laws knowledge
- Comprehensive global regulations knowledge
- Comprehensive guidelines knowledge
- Good understanding of global regulatory agencies
- Leading CTA submission experience
- Leading IND submission experience
- Leading sNDA/NDA/MAA/Variations submission experience
- University degree in Medicine, Pharmacy, Life Sciences or Chemistry
- Several years clinical/industry/health authority experience
- Preferably global or European role experience
- Good CMC knowledge
- Experience in Oncology therapeutic field
- Experience in CNS therapeutic field
- Experience in Cardio-Renal therapeutic field
- Strong information searching skills
- Strong summarization skills
- Strong assessment skills
- Microsoft Word proficiency
- Microsoft Excel proficiency
- Microsoft PowerPoint proficiency
- Microsoft Outlook proficiency
- Strong analytical skills
- Problem solving ability
- Strong communication skills
- Strong presentation skills
- Excellent English language command
- Experience in cross-functional project teams
- Experience in multi-cultural project teams
- Communicating with cross-functional project teams
- Communicating with multi-cultural project teams
- Involving internal and external experts
- Strong knowledge in European Regulatory Affairs
- Experience in European Regulatory Affairs
- Strategic European Regulatory Affairs aspects
- Operational European Regulatory Affairs aspects
Tasks
- Provide global regulatory expertise for pre-clinical, clinical, and commercial areas
- Ensure regulatory and competitive intelligence is searched, summarized, and disseminated
- Collaborate with Regulatory Management to establish clear regulatory pathways
- Create accurate and timely documents for submission and final approval
- Develop global regulatory strategy and plan for investigational and marketed drugs
- Manage lifecycle regulatory activities in alignment with Therapeutic Area Lead
- Serve as primary contact to Competent Authorities in Europe and other regions
- Identify and obtain regulatory intelligence and precedent approvals
- Translate complex global requirements and assess regulatory challenges
- Lead cross-functional teams to develop global regulatory plans and address issues
- Respond to health authority queries and meet regulatory obligations
- Develop and lead strategy for Health Authority interactions and communications
- 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 and review responses for health authority submissions
- Review submission documents for consistency and strategic alignment
- Interact with regulatory agencies and document conversations
- Contribute to product registration, progress reports, and adverse experience reports
- Collaborate with outsourced suppliers for regulatory document preparation
- Identify and communicate major regulatory issues to stakeholders
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Otsuka Pharma GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Otsuka Pharma GmbH
Industry
Pharmaceuticals
Description
Otsuka Pharma GmbH ist ein Unternehmen, das sich auf pharmazeutische Produkte spezialisiert hat.
Not a perfect match?
- Merz Therapeutics
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