As Senior Manager Regulatory CMC, you will lead and drive global regulatory CMC activities for New Chemical Entities (NCE) and or drug-linkers for Antibody Drug Conjugates (ADC) during all clinical ...
... you will coordinate and execute Regulatory Affairs tasks for our product portfolio. ... facing environment.Professional experience in Regulatory Affairs, ideally with biocidal product regulationsEcotoxicological ...
... ensure ongoing compliance. Partner with Regulatory Project Management and Submission Management.• ... least 3 years experience in drug development, preferably in regulatory affairs.• Demonstrated matrix leadership skill.• Excellent ...
... optimization and selection of drug candidates in preclinical projects of ... human PK characteristics of drug candidates based on in-vitro ... and dose. Quantitative predictions of drug-drug-interactions of drug candidates employing appropriate PBPK modelling ...
... der Chemieindustrie suchen wir einen Regulatory Affairs Specialist (m w d) am ... verwandten Bereich, vorzugsweise in der Regulatory Affairs oder ProduktstewardshipErfahrung in der Zusammenarbeit ...
... projects (NCEs) and antibody-drug-conjugates. Furthermore, you contribute to ... to the head of Drug Substance Development Chemical Sciences within ... knowledgeExperience with high potent drugs and antibody drug conjugates is of advantageBroad interdisciplinary ...
... .Solid understanding of translational sciences, regulatory requirements, and work packages (nonclinical and clinical). Experience with biological drug candidates is a plus.Expertise ...
... | softgarden View job here IT-Manager Digitalisierung IT Manager BI (m w d) bis ... zum nächstmöglichen Zeitpunkt als IT-Manager Digitalisierung IT Manager BI (m w d) Das ...
... role, you will contribute to drug discovery approaches from hit finding ... -of-the-art methodologies of drug discovery. You will either lead ... modulators, targeted protein degraders, and drug linker payloads for antibody-drug conjugates.Your tasks will include ...
... a timely manner to support regulatory submissions and program´s decision-marking.You will lead the design, implementation and oversight of disease or drug-specific Non-Interventional (NIS) RWE ...