Senior Specialist in Regulatory Affairs focusing on site transfers for veterinary medicinal products. Maintaining CMC dossiers and ensuring regulatory compliance with cross-functional teams.
Responsibilities
Maintain and update regulatory CMC dossiers
(Co-)develop regulatory strategies and prepare documentation for change notifications, ensuring compliance with current regulatory quality standards
Respond promptly to inquiries from countries and regulatory authorities
Provide technical regulatory support to other functions
Collect and maintain regulatory information, accounting for the associated processes, and manage the relevant systems and databases
Requirements
Master's degree in Pharmacy, Chemistry, Food Chemistry or Biology
Ideally, professional experience in comparable positions within the pharmaceutical industry
Reliable, flexible, team-oriented and proficient in MS Office
Careful and responsible working style
Strong organizational skills combined with excellent communication skills in an international environment
Very good verbal and written language skills (English essential, German desirable)
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