Job Description
CMC Regulatory Senior ScientistOur client, a global pharma company, is currently recruiting for a CMC Regulatory Senior Scientist to join their team on a permanent basis. This is an excellent opportunity to join a global team of regulatory experts. This role offers hybrid working. As CMC Regulatory Senior 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 and maintain marketing authorizations.Partner with CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers.Ensure successful preparation of CMC dossiers and variation packages to support product submissions.Provide regulatory leadership and support for products listed as the primary responsibilities.Develop, plan, and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with CMC Regulatory Scientists and other functional representatives.Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.Partner 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 countries.Manage 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 manner.Partner with CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product and site renewals, as well as license expiry, where applicable.Manage authoring and content reviews of simple RtQs.Review/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.RequirementsMinimum degree in Life Sciences, ideally an advanced degree (MSc, PhD, PharmD preferred), in a related biological and life science field.Regulatory experience in either a pharmaceutical or biotech environment.Knowledge of regulatory and compliance guidelines in pharma/biopharma.Knowledge of Manufacturing and Quality work processes as well as GMP compliance.Proven ability to effectively influence within a team.Communicate effectively, particularly with the view to influencing and developing in an international matrix environment, demonstrating a wider business perspective.Displays a conscientious attitude, and possesses excellent verbal and written communication skills.Fully proficient in RIM and in using common Microsoft applications to create and present work.Good organizational skills, with the ability to prioritize and be self-motivating.Work well collaboratively within a team, or as an individual contributor.Possesses excellent attention to detail and ability to effectively prioritize.Proven effective teamwork skills; able to adapt to diverse interpersonal situations.For more information please contact sinead.cullen@lifescience.ie or +353879500821. #J-18808-Ljbffr