Global CMC Regulatory Manager — Strategy & Submissions

Us Tech Solutions; Madison (NJ); Vor Ort; USD 138.000 - 141.000; Teilzeit

Zusammenfassung

US Tech Solutions in Madison, NJ seeks a CMC Regulatory Manager to provide strategic regulatory expertise across development through post-approval for biotech products. You will interface with Global Regulatory Sciences and related teams, guide change management, and ensure regulatory success for complex CMC submissions.

The role emphasizes strong analytical skills, cross-functional leadership, and effective communication with Health Authorities, with a 6-month contract and potential extension.

Qualifikationen

• 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

Aufgaben

• Support 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

Kenntnisse

CMC regulatory

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Risk mitigation

Communication skills

Travel readiness

Ausbildung

BA/BS degree

Tools

Electronic systems

Jobbeschreibung

US Tech Solutions in Madison, NJ seeks a CMC Regulatory Manager to provide strategic regulatory expertise across development through post-approval for biotech products. You will interface with Global Regulatory Sciences and related teams, guide change management, and ensure regulatory success for complex CMC submissions.

The role emphasizes strong analytical skills, cross-functional leadership, and effective communication with Health Authorities, with a 6-month contract and potential extension.