Job Title: Global Regulatory CMC Manager Duration: This is a 6-month assignment.
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; 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). Support project teams (e.g. for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions Provide strategic CMC regulatory expertise for development project teams Participate in product fact finding meetings with supervision Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success Provide technical teams insight into regulatory health authority expectations Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success Support the preparation of CMC policies and procedures 4-6+ years pharmaceutical or related experience (min BA/BS). 4+ years of CMC regulatory or related experience
Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicable
Knowledge 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 applicable
Demonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently
Ability to interpret global regulations and guidance documents
Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
Search for opportunities for continuous improvement
This position may require up to 5% of travel
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This position is listed as full time and onsite.