Katalyst CRO
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Senior Manager, CMC Regulatory Affairs
role at
Katalyst CRO .
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. Get AI-powered advice on this job and more exclusive features.
Responsibilities
Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals.
Align CMC regulatory plans with cross-functional development and manufacturing teams.
Execute regulatory strategies: track and manage progress within defined timelines.
Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates.
Write Module 3 sections to support INDs, IMPDs, NDAs, and MAAs, independently and with team collaboration.
Evaluate health authority questions and lead responses with cross-functional SMEs.
Prepare questions and briefing documents for Health Authority meetings like Type C with FDA and Scientific Advice with EMA.
Assess manufacturing and quality changes for impact on filings and provide strategic regulatory guidance.
Develop, review, and comment on complex CMC documentation for regulatory submissions.
Collaborate cross-functionally to generate and review CMC regulatory documents.
Disseminate global CMC regulations and guidelines with appropriate interpretation.
Requirements
BS or BA in a scientific or technical discipline; advanced degree preferred. Equivalent education and experience may be considered.
At least 8 years industry experience, with 5+ years in regulatory affairs with CMC responsibilities.
Thorough understanding of drug development, pharmaceutical industry, and healthcare environment, including US FDA and international regulations (EMA, ICH, Health Canada, LATAM), with expertise in small molecule and oligonucleotide products preferred.
Proven ability to work effectively in a fast-paced, innovative environment.
Experience navigating matrixed organizations and working with all management levels and stakeholders.
Veeva Vault experience is a plus.
Highly organized, detail-oriented, with strong communication skills.
Professionalism, integrity, and confidence in work approach.
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Senior Manager, CMC Regulatory Affairs
role at
Katalyst CRO .
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. Get AI-powered advice on this job and more exclusive features.
Responsibilities
Actively participate on CMC development teams to plan regulatory strategies by defining pathways and milestones for submissions to support development activities leading to successful study authorizations and ultimately marketing approvals.
Align CMC regulatory plans with cross-functional development and manufacturing teams.
Execute regulatory strategies: track and manage progress within defined timelines.
Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization of assigned drug candidates.
Write Module 3 sections to support INDs, IMPDs, NDAs, and MAAs, independently and with team collaboration.
Evaluate health authority questions and lead responses with cross-functional SMEs.
Prepare questions and briefing documents for Health Authority meetings like Type C with FDA and Scientific Advice with EMA.
Assess manufacturing and quality changes for impact on filings and provide strategic regulatory guidance.
Develop, review, and comment on complex CMC documentation for regulatory submissions.
Collaborate cross-functionally to generate and review CMC regulatory documents.
Disseminate global CMC regulations and guidelines with appropriate interpretation.
Requirements
BS or BA in a scientific or technical discipline; advanced degree preferred. Equivalent education and experience may be considered.
At least 8 years industry experience, with 5+ years in regulatory affairs with CMC responsibilities.
Thorough understanding of drug development, pharmaceutical industry, and healthcare environment, including US FDA and international regulations (EMA, ICH, Health Canada, LATAM), with expertise in small molecule and oligonucleotide products preferred.
Proven ability to work effectively in a fast-paced, innovative environment.
Experience navigating matrixed organizations and working with all management levels and stakeholders.
Veeva Vault experience is a plus.
Highly organized, detail-oriented, with strong communication skills.
Professionalism, integrity, and confidence in work approach.
#J-18808-Ljbffr