Regulatory Quality Compliance Manager
Regulatory Quality Compliance Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Title: Regulatory & Quality Compliance Manager (m/f/d)
Job Location: Waltham MA USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
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 submissionreadiness 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
- Expert and interface function to the development department marketing production quality department as well as to the regional/local approval unit
- International coordination and communication in a global organization
- Successfully completed technical or scientific studies
- Experience in project management respectively change control process
- Experience in regulatory affairs or in a quality environment ideally in a pharmaceutical/medical environment of advantage
- Knowledgeable in relevant regulations (such as registration of medicinal products change control GxP EU requirements CMC ICH M4 etc.)
- Language requirements: Fluent in English advanced in German
- Structured and independent way of working
- Strong communication skills
- Ability to work in and with a team
- Assertiveness
There is a lot for you to discover at Fresenius because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you for your professional future with meaning:
- The opportunity to work on a mobile basis
- Whether in front of or behind the scenes you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for selfdetermined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking to find the best not the fastest solution together
- A large number of committed people with a wide range of skills talents and experience
- The benefits of a successful global corporation with the collegial culture of a mediumsized company
- Supporting the department in crosssite activities to monitor product quality and regulatory compliance
/jobs/view/b7cdcb41f69392c97da2fd822dd1954e
Employment Type
Full Time
