Main Responsibilities:
-Maintain an awareness of, and provide feedback on, client, industry and regulatory developments to input into the strategic development of the department
-Provide up to date regulatory advice to internal and external clients as required
-Prepare, review, submit and project manage regulatory submissions in compliance with the applicable SOPs, regulatory guidelines and legislation
-Attend client project meetings (face to face and via teleconference) as required
-Maintain electronic and hard copy project and regulatory files
-Participate in business development activities as required
-Provide input into monthly invoicing
-Develop and maintain effective working relationships with internal and external clients, regulatory authorities and suppliers
-Maintain high levels of customer service to meet client expectations at all times
Experience Required:
-Experience from working in a pharmaceutical/healthcare product development environment
-An overall understanding of the drug development process and the role of regulatory affairs within that process
-Science degree preferable