Position Overview
The Clinical Regulation Specialist is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives, regulatory and legal requirements. The Regulatory Affairs Specialist reports to the Director of Quality Assurance and Regulatory Affairs
Responsibilities and Main Tasks
§ Comprehensive and professional regulatory support of clinical trials.
§ Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies.
§ Understanding of the EU/FDA/USDA regulatory guidelines
Provide expert regulatory input to strategic decision-making Responsible for the preparation and maintenance of the regulatory dossier for EU/FDA/USDA and other relevant regulatory authorities worldwide.
§ Collecting and evaluation of scientific and technical data, clinical, and medical information.
§ Primary contact for the cross-functional company teams for the regulatory guidelines and recommendations for regulatory pathways throughout product development.
§ Keep up to date with changes in regulatory legislation and guidelines.
Job requirements
§ Fluent in oral and written in English.
§ Knowledge of Local, European and USA pharmaceutical relevant guidelines
§ Practical experience of at least 5 years in the regulatory aspect from the pharmaceutical industry.
Significant advantage for experience in animal drug regulation.
§ Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to
successful dossier preparation, submission and maintenance.
§ Education:
Master of Science in Life Sciences.
PhD in life sciences or a veterinarian – a significant advantage
