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Integrated Resources, Inc ( IRI ) · Madison, New Jersey
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).
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
Provide strategic CMC regulatory expertise for development project teams
Provide strategic input to development and GO teams to mitigate drug supply issues
Interpret global regulations and guidance
Identify, communicate and propose resolution to routine issues
Participate in product fact finding meetings with supervision
Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor on complex topics
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
Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
Support the preparation of CMC policies and procedures
Minimum BA/BS Degree
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 identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness
Ability to interpret global regulations and guidance documents
Demonstrated ability to be solution-oriented
Seeks multiple perspectives and listens openly to others’ points of views
Enables and demonstrates the courage to speak up on issues and risks as well as on the good news
Demonstrates ownership of results within (and beyond) area of responsibility
Sets clear and high expectations and holds self and others accountable for decisions and results achieved
Search for opportunities for continuous improvement
Proficient with electronic systems
This position may require up to 5% of travel
Details
| Company | Integrated Resources, Inc ( IRI ) |
| Location | Madison, New Jersey |
| Type | FULL TIME |
| Niche | Full-time |