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 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
Utilize electronic systems for dossier creation and tracking
Qualifications:
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
Strong oral and written skills
Proficient with electronic systems
This position may require up to 5% of travel
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Madison, NJ
Salary
$100–$102 Per Hour
Skills
Analysis Skillsunmatched
Cell Biologyunmatched
Change Controlunmatched
Change Managementunmatched
Channel Strategiesunmatched
Clinical Information Systemsunmatched
Clinical Trialunmatched
Communication Skillsunmatched
Content Developmentunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Database Administrationunmatched
Drug Developmentunmatched
Drug Productsunmatched
Establish Prioritiesunmatched
GPS (Global Positioning System)unmatched
Interpret Regulationsunmatched
Manufacturing Analysisunmatched
Manufacturing Requirementsunmatched
Marketingunmatched
Marketing Softwareunmatched
Medical Equipmentunmatched
Medical Recordsunmatched
Multitaskingunmatched
Pediatricsunmatched
People Managementunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Project Lifecycleunmatched
Project/Program Managementunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Research Skillsunmatched
Risk Analysisunmatched
Small Moleculesunmatched
Support Documentationunmatched
Team Lead/Managerunmatched
Willing to Travelunmatched
Writing Skillsunmatched
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