Description
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 perform 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 database to address external questions regarding drug products.
Position Summary / Objective
The Senior Manager, GRS-CMC 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 & background packages (including participating / leading HA meetings); & / or post-approval submissions.
In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
Position 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 extensions.
- Provide strategic CMC regulatory expertise for development project teams
- Provide strategic input to development & 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
- Interface with the US FDA for CMC submissions and CMC-related issues (either with the USL or directly)
- Communicate with project teams; in particular 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, GRTL, Line manager etc.)
Degree Requirements
Minimum BA / BS Degree
Experience Requirements
- 3-5+ years pharmaceutical or related experience (min BA / BS). 2+ years CMC regulatory or related experience.
- Knowledge of CMC regulatory requirements for advanced therapies and / or biologics during development and post-approval.
- Knowledge of pharmaceutical development, including advanced therapies and / or biologic upstream and downstream processes, analytical methods, and biologic / device combination products.
- 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.
- Strong oral and written skills.
- Proficient with electronic systems
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