PANDA INTERNATIONAL is a specialist recruitment agency dedicated to placing high-level candidates in freelance and temporary roles within the Pharmaceutical, Medical Device, Biotech and Food sectors across Europe. By working closely with candidates and companies in meeting challenging business demands, the Panda team has developed an extensive client base consisting of the world’s leading Life Sciences organizations.
One of our pharmaceutical clients in Antwerp is looking for a Senior Associate Director. This person would be responsible for Global Labeling in the Global Regulatory Affairs Department.
Responsible for creation and maintenance of the Company Core Datasheets
Writing and editing Target labels and managing the label process throughout the product life cycle
Run the Labeling Working Group process
Involved in the development of labeling strategy and label negotiation
Interfacing with the labeling operations function defending labeling position with any potential issues
Ensure changes to labeling operations are tracked and involvement in label audits
Creation and maintenance of US Package Inserts, EU Summaries of Product Characteristics, EU centralized procedure/Mutual recognition Summaries of Product Characteristics
5 years of experience in the pharmaceutical industry
Understanding of drug development process
Knowledge of US and EU regulations in relation to package labels including regulatory submissions, approval process, and labeling requirements
Medical writing and editing skills in XML-based environment is a plus
Knowledge of labeling interfaces within manufacturing and commercialization processes
Minimum bachelor Degree in Life Sciences
Fluent in written and spoken English, Dutch preferable
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