Katalyst CRO
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CMC Regulatory Affairs Consultant
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Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Consultant
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. Serve as the CMC regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are adequately met. Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional and country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives. Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle. Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
Responsibilities
Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. Serve as the CMC regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are adequately met. Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional and country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives. Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle. Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
Requirements
An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is desired. 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules. Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.). Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues Demonstrated experience in effective collaboration with internal and external stakeholders Able to prioritize and manage multiple projects simultaneously in a dynamic company environment. Effective written and verbal communication skills and good interpersonal skills Global regulatory experience across major regions such as the US, EU, and APAC is highly preferred. Evidence of prior success in Health Authority interactions is a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Consultant jobs in
Dallas, TX . Frisco, TX $100,000.00-$130,000.00 1 month ago Food Safety and Regulatory Affairs ManagerSenior Counsel (Bank Regulatory & Corporate Governance)Capital Markets Regulatory Change - Consultant/Senior ConsultantSenior Consultant - Financial Services Risk Management - Bank Regulatory Reporting and Remediation Dallas, TX $93,225.00-$170,912.00 6 days ago Regulatory Affairs Specialist II, Dangerous Goods Transportation United States $90,000.00-$115,000.00 1 week ago Principal/ Sr. Consultant - Regulatory Reporting – Risk and Compliance - Financial Services We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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CMC Regulatory Affairs Consultant
role at
Katalyst CRO 1 day ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Consultant
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. Serve as the CMC regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are adequately met. Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional and country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives. Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle. Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.
Responsibilities
Provide CMC regulatory strategies to support the clinical development and eventual marketing approval of investigational products. Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions, including initial submission of IND, IMPD/CTA, NDA, MAA, and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs. Serve as the CMC regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are adequately met. Work with the corporate regulatory team, CMC SMEs, and CROs to identify regional and country-specific CMC requirements to support global applications and to drive the CMC submission timelines to meet business objectives. Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle. Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, providing interpretation to internal stakeholders.
Requirements
An advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field is desired. 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules. Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, etc.). Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues Demonstrated experience in effective collaboration with internal and external stakeholders Able to prioritize and manage multiple projects simultaneously in a dynamic company environment. Effective written and verbal communication skills and good interpersonal skills Global regulatory experience across major regions such as the US, EU, and APAC is highly preferred. Evidence of prior success in Health Authority interactions is a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Consultant jobs in
Dallas, TX . Frisco, TX $100,000.00-$130,000.00 1 month ago Food Safety and Regulatory Affairs ManagerSenior Counsel (Bank Regulatory & Corporate Governance)Capital Markets Regulatory Change - Consultant/Senior ConsultantSenior Consultant - Financial Services Risk Management - Bank Regulatory Reporting and Remediation Dallas, TX $93,225.00-$170,912.00 6 days ago Regulatory Affairs Specialist II, Dangerous Goods Transportation United States $90,000.00-$115,000.00 1 week ago Principal/ Sr. Consultant - Regulatory Reporting – Risk and Compliance - Financial Services We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr