Global Regulatory CMC Manager

Job Description

Job Title: Global Regulatory CMC Manager

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Duration: This is a 6-month assignment.

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Summary:

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• 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.
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• 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.
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Responsibilities:

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• 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 extensions
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• Provide strategic CMC regulatory expertise for development project teams
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• Provide strategic input to development and GO teams to mitigate drug supply issues
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• Interpret global regulations and guidance
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• Identify, communicate and propose resolution to routine issues
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• Participate in product fact finding meetings with supervision
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• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics
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• Communicate with project teams; with regards to technical issues that may impact regulatory submissions, strategy, or success
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• Provide technical teams insight into regulatory health authority expectations
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• Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success
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• Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
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• Support the preparation of CMC policies and procedures
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• Utilize electronic systems for dossier creation and tracking
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Qualifications:

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• Minimum BA/BS Degree
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• 4-6+ years pharmaceutical or related experience (min BA/BS). 4+ years of CMC regulatory or related experience
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• Knowledge of CMC regulatory requirements for advanced therapies and/or small molecules, biologics, cell therapy during development and post-approval as applicable
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• 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
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• 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
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• Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness
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• Ability to interpret global regulations and guidance documents
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• Demonstrated ability to be solution-oriented
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• Seeks multiple perspectives and listens openly to others’ points of views
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• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
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• Demonstrates ownership of results within (and beyond) area of responsibility
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• Sets clear and high expectations and holds self and others accountable for decisions and results achieved
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• Search for opportunities for continuous improvement
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• Strong oral and written skills
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• Proficient with electronic systems
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• This position may require up to 5% of travel
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