- Characterizing safety and DMPK for new animal pharmaceutical research and development projects, line extensions and maintenance of existing licensed products.
- Developing risk assessments and technical sections of regulatory submissions for user safety, environment safety, consumer safety and target animal safety.
- Non-clinical study design, implementation, and quality output, when performed by self or others, including resource and budget planning from protocol to execution to final study report for submission to regulatory agencies for animal pharmaceutical projects.
- Subject matter expert representing his/her function e.g. on project teams, research teams, development teams, and regulatory authority meetings. Influences internal DSD team and global teams in area of expertise.
- Establishment of PK-PD relationships and conduct of pivotal PK studies and bioequivalence/relative bioavailability studies for bridging development studies and for life cycle management projects performed by self and others; estimation of exposures relevant for the calculation of Maximum Residue Limits (MRL) and tolerances,.
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