STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-timeWith HomeofficeSenior
Bad Vilbel
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OTOtsuka Pharma GmbH
Associate Director Global Regulatory Affairs(m/w/x)
Frankfurt am Main
from USD 80,000 - 100,000 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for investigational and marketed pharmaceutical products. Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions required. Unlimited PTO, 401k matching.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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
from USD 80,000 - 100,000 / year
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for investigational and marketed pharmaceutical products. Experience leading CTA, IND, sNDA/NDA/MAA/Variations submissions required. Unlimited PTO, 401k matching.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Benefits
Healthcare & Fitness
- Health insurance
Retirement Plans
- 401k matching
More Vacation Days
- Unlimited PTO
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.
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?
- STADA Arzneimittel AG
Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
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Team Lead Regulatory Affairs Regions(m/w/x)
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Senior Director Regulatory Global Specialty / Biosimilar Development(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorBad Vilbel - Lilly Deutschland GmbH
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Full-timeWith HomeofficeExperiencedBad Homburg vor der Höhe