Regulatory & Quality Compliance Manager (m/f/d)

Fresenius Medical Care; Guadalajara; A distancia; USD 50,000 - 70,000; Jornada completa

Descripción de la vacante

Fresenius Medical Care is seeking a Global Product Center Manager for Sterile Fluids in Guadalajara. The role involves supporting regulatory projects, managing international teams, and ensuring compliance with medicinal product regulations. Ideal candidates have solid technical backgrounds, project management skills, and fluency in English and German.

Servicios

Flexible remote working options

Opportunities for self-directed career planning

Innovative corporate culture

Diverse team environment

Formación

• Experience in regulatory affairs or a quality environment, preferably in pharma.
• Knowledge of GxP, EU requirements, etc.
• Fluent in English, advanced in German.

Responsabilidades

• Support regulatory development and registration projects.
• Manage global teams in change projects.
• Organize regulatory documentation submissions.

Conocimientos

Project management

Regulatory affairs

Strong communication

Collaborative teamwork

Educación

Technical or scientific studies

Descripción del empleo

The internal Job Title is called Global Product Center Manager (m/f/d) - Sterile Fluids (Medicinal Products).

Main Responsibilities:

• Support as regulatory expert development and new registration projects (Medicinal Products)
• Project management for the implementation of projects to comply with regulatory requirements
• Organization of submission-readiness of regulatory documentation (e.g., CMC relevant parts)
• Organize and support global creation and maintenance of regulatory documentation
• Management of global teams within change projects
• Act as an expert and interface to the development department, marketing, production, quality department, and regional/local approval units
• Coordinate and communicate internationally within a global organization

What we expect?

• Successfully completed technical or scientific studies
• Experience in project management or change control processes
• Experience in regulatory affairs or a quality environment, preferably in a pharmaceutical/medical setting
• Knowledge of relevant regulations (such as registration of medicinal products, change control, GxP, EU requirements, CMC, ICH M4, etc.)
• Language skills: Fluent in English, advanced in German
• Structured and independent working style
• Strong communication skills
• Ability to work collaboratively in a team
• Assertiveness

Our offer to you:

Discover numerous opportunities at Fresenius, regardless of your expertise (m/f/d) and experience, for your professional future with purpose:

• The possibility to work remotely
• Contribute to making better medicines accessible worldwide
• Opportunities for self-directed career planning and professional growth
• A corporate culture encouraging innovative thinking to find the best solutions together
• A diverse team with a wide range of skills, talents, and experiences
• Benefits of a global corporation combined with the culture of a medium-sized company

• Support the department in cross-site activities to monitor product quality and regulatory compliance