Job Description
CMC Regulatory Principal ScientistOur client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses.ResponsibilitiesProvide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizationsPartner with CMC Regulatory Scientists to manage outsourcing activities & contract manufacturersEnsure successful preparation of CMC dossiers and variation packages to support product submissionsProvide regulatory leadership and support for products listed as the primary responsibilitiesDevelop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with CMC Regulatory Scientists and other functional representativesPrepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirementsPartner with the CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countriesManage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely mannerPartner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicableManage authoring and content reviews of simple RtQsReview/Approve regulatory documents such as: full and core CMC Dossiers , variation packages, post-approval commitments with health authorities and answers to questions received from health authorities CMC Regulatory Principal ScientistOur client, a global pharma company, are currently recruiting for a CMC Regulatory Principal Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team very strong of regulatory experts. This role offers hybrid working. As CMC Regulatory Principal Scientist, you will lead various aspects of the global marketing authorization submission management processes, help manage submission content for Drug Substance and Drug Product, provide guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses.ResponsibilitiesProvide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain & maintain marketing authorizationsPartner with CMC Regulatory Scientists to manage outsourcing activities & contract manufacturersEnsure successful preparation of CMC dossiers and variation packages to support product submissionsProvide regulatory leadership and support for products listed as the primary responsibilitiesDevelop, plan and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with CMC Regulatory Scientists and other functional representativesPrepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirementsPartner with the CMC Regulatory Scientist to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for the Rest of the World countriesManage submission timelines with relevant teams (e.g. supply chain, QC, manufacturing, clinical teams), monitor approval status and communicate change status to interested personnel in a timely mannerPartner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product & site renewals as well as license expiry, where applicableManage authoring and content reviews of simple RtQsReview/Approve regulatory documents such as: full and core CMC Dossiers , variation packages, post-approval commitments with health authorities and answers to questions received from health authoritiesRequirementsMinimum degree in Life Sciences, ideally an advanced degree (MSc, PhD, PharmD preferred), in related biological and life science fieldRegulatory experience in either a pharmaceutical or biotechKnowledge of regulatory and compliance guidelines in pharma/ biopharmaKnowledge of Manufacturing & Quality work processes as well as GMP complianceProven ability to effectively influence within a teamCommunicate effectively, particularly with the view to influencing and developing in an international matrix environment, hereby demonstrating a wider business perspectiveDisplays conscientious attitude, and possesses excellent verbal and written communication skillsFully proficient in RIM and in using common Microsoft applications to create and present workGood organizational skills, with the ability to prioritize and be self-motivatingWork well collaboratively within a team, or as an individual contributorPossesses excellent attention to detail and ability to effectively prioritizeProven effective teamwork skills; Able to adapt to diverse interpersonal sFor more information please contact sinead.cullen@lifescience.ie or +353879500821 #J-18808-Ljbffr