Katalyst CRO
CMC Regulatory Affairs Manager
Katalyst CRO - Foster City, California, United States, 94420
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Overview
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CMC Regulatory Affairs Manager
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Katalyst CRO 13 hours ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets. Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities. Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
Responsibilities
Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets. Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities. Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
Requirements:
BA/BS, MS or Ph. D or equivalent education. Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience. Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products. Biologics experience or drug-device combination product experience would be an advantage. A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions. Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs. Experience representing CMC regulatory affairs on regulatory and cross functional teams. Excellent written and verbal communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
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CMC Regulatory Affairs Manager
role at
Katalyst CRO 13 hours ago Be among the first 25 applicants Join to apply for the
CMC Regulatory Affairs Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets. Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities. Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
Responsibilities
Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements. Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the international markets. Liaise with colleagues in Regulatory Affairs therapeutics teams, , Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities. Maintain a current awareness of CMC registration requirements in each of the international regions and communicate key regulatory intelligence to the organization on a timely basis.
Requirements:
BA/BS, MS or Ph. D or equivalent education. Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience. Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products. Biologics experience or drug-device combination product experience would be an advantage. A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions. Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs. Experience representing CMC regulatory affairs on regulatory and cross functional teams. Excellent written and verbal communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Legal Industries Business Consulting and Services Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Regulatory Affairs Manager jobs in
Foster City, CA . Senior Regulatory Affairs Specialist - Vascular (on-site)
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Sr Regulatory Affairs Specialist (Remote) - Shockwave
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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