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Regulatory Affairs - Animal Health
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Full-time
- Job Title: Regulatory Affairs - Animal Health
- Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports
- Experience in reviewing of CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guideline.
- Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.
- Comparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPC.
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