Global Regulatory CMC Manager

Job Title: Global Regulatory CMC ManagerDuration: This is a 6-month assignment.

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Summary:The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also performs regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain databases to address external questions regarding drug products.The GRS-CMC Manager is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses and background packages (including participating / leading HA meetings with support); and/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO). The GRS-CMC Senior Manager II will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.Responsibilities:Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensionsProvide strategic CMC regulatory expertise for development project teamsProvide strategic input to development and GO teams to mitigate drug supply issuesInterpret global regulations and guidanceIdentify, communicate and propose resolution to routine issuesParticipate in product fact finding meetings with supervisionInterface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topicsCommunicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or successProvide technical teams insight into regulatory health authority expectationsIdentify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory successEnsures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)Support the preparation of CMC policies and proceduresUtilize electronic systems for dossier creation and tracking
Qualifications:Minimum BA/BS Degree4-6+ years pharmaceutical or related experience (min BA/BS). xzbcwsv 4+ years of CMC regulatory or related experienceKnowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicableKnowledge of pharmaceutical development, including advanced therapies and/ or small molecules, biologic, cell therapy upstream and downstream processes, analytical methods, and small molecule or biologic/device combination, cell therapy products as applicableDemonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independentlyAbility to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timelinessAbility to interpret global regulations and guidance documentsDemonstrated ability to be solution-orientedSeeks multiple perspectives and listens openly to others’ points of viewsEnables and demonstrates the courage to speak up on issues and risks as well as on the good newsDemonstrates ownership of results within (and beyond) area of responsibilitySets clear and high expectations and holds self and others accountable for decisions and results achievedSearch for opportunities for continuous improvementStrong oral and written skillsProficient with electronic systemsThis position may require up to 5% of travel