Our client is a professional Biotechnology and Pharmaceutical organization, based in Zuid-Holland Netherlands.
My client, a succesful Biotech company, based in Zuid-Holland is looking for an interim Regulatory Affairs Manager.
This role requires a strong and proven leader to shape and direct the regulatory affairs of the company, including strategy, the submission of new drug and biologics applications to the FDA and international regulators, and the building of a world-class regulatory organisation.
Assist to ensure the successful preparation and filing of all regulatory submissions including INDs/CTAs, NDA/MAAs, amendments/supplements, annual reports, study protocols and study reportsPerform regulatory research and regulatory intelligence as needed.
Provide administrative and related project support
Contact company employees to gather information and prepare reports Establish standards for document preparation, timeline development/management, and procedures to receive final, submission ready documents in eCTD and CTD format.
Support production, assembly and publishing of submission documents
Responsible for data entry, filing, archiving, and maintenance of submission tracking databases.
Create and maintain regulatory standard operating procedures Review documents for completeness and compliance with regulatory requirements
Provide formatting support for documents to ensure consistency within and between documents and with document templates
Bachelors degree in the sciences or other disciplines, or equivalent industry experience.
A minimum of 5 years as Regulatory Affairs Manager.
Strong understanding of the drug development process, excellent communication skills, both oral and written as well as a strong attention to detail.
Electronic submissions experience is a plus.
Effective planning and organizational skills and strong computer skills including MS Word experience.
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