Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist in Non-Clinical Toxicology - Bad Homburg vor der Höhe, Hessen - Fresenius Medical Care
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Regulatory Affairs Specialist in Non-Clinical Toxicology
vor 2 Monaten
Your Responsibilities:
- Develop and manage non-clinical documentation for pharmaceutical products, ensuring compliance with CTD modules and aligning with Global Drug Regulatory Affairs and pertinent stakeholders.
- Act as the subject matter expert for the regulatory content mentioned above.
- Serve as the non-clinical authority for CTD module inquiries.
- Address queries related to marketing authorization applications, variations, and audits/inspections within the stipulated timelines set by regulatory bodies.
- Proactively collaborate with various stakeholders (clinical, pharmacovigilance, regulatory, labeling) as necessary, particularly when evaluating non-clinical information or related topics.
- Function as the primary contact for internal and external non-clinical inquiries.
- Establish non-clinical strategies for pharmaceutical products, particularly in the context of new product development, as part of cross-functional teams.
- Conduct regular assessments of existing non-clinical documentation to determine the need for updates based on the latest scientific knowledge and guidelines, coordinating updates with relevant stakeholders as needed.
- Support initiatives aimed at expanding the footprint of Fresenius Medical Care in emerging markets and establishing new global marketing authorizations.
Your Qualifications:
- Master's degree in a scientific discipline.
- Certification as a Toxicologist is preferred (European registered toxicologist or American board of toxicologists).
- Specialized training in the preparation of non-clinical drug dossier components.
- Extensive understanding of the drug development and registration processes.
- A minimum of 3-5 years of experience in a related position.
- Strong project management capabilities with a highly organized and systematic approach.
- Exceptional stakeholder management and communication skills, fostering transparent dialogue while effectively managing conflicts.
- Ability to articulate and clarify complex topics to stakeholders at all levels.
- Fluency in business English is essential.
- Additional language skills, particularly in German, are advantageous.
- Commitment to continuous learning and adaptability in dynamic environments.
- Capability to engage with all management levels to drive positive change.
- Willingness to undertake limited business travel.
Why Join Us?
At Fresenius Medical Care, we provide a platform for you to contribute to meaningful healthcare advancements. We are dedicated to your professional growth and offer a collaborative environment where you can work alongside passionate individuals striving for excellence in patient care.
Our Commitment to Diversity:
Joining our team means being part of a diverse workforce that values unique backgrounds, cultures, and perspectives. We are committed to fostering an inclusive workplace where every employee feels appreciated.
Stability and Growth:
We are recognized as a leader in the production of hemodialysis machines, driven by innovation and sustainable growth. This role offers the stability and security necessary to enhance the lives of our patients.
Learning Opportunities:
We provide access to world-class training programs, leadership development, and digital educational resources available to all employees around the clock.
Work-Life Balance:
We promote a healthy work-life balance through flexible working arrangements, including options for remote work and part-time schedules.
