JOB FUNCTION
Project Manager, Regulatory Affairs
MAIN RESPONSIBILITIES
· Manage project submissions as assigned by Regulatory Affairs leadership
· Support the management of key projects, including execution, for submission, approval, and launch
· Review, prepare and author documents for regulatory submissions including clinical trial applications, marketing authorisation applications, post-authorisation submissions, regulatory meeting packages, response to regulatory queries, etc.
· Monitor progress of applications and variations submitted to regulatory authorities
· Provide regulatory input and recommendations for product development in line with current regulatory expectations
· Work with relevant stakeholders to ensure project timelines are met
· Maintain knowledge of the most up-to-date regulations to ensure regulatory compliance
· Other duties as assigned by Regulatory Affairs leadership
EDUCATION AND EXPERIENCE
· At least a bachelor’s degree in chemistry, biology, or related science
· Minimum 3-5 years of experience in regional and international regulatory affairs support of content submission, compilation, and publishing
· Minimum 3 years of experience in project management in a pharmaceutical or health-related industry
· Prior experience with EMA and/or FDA would have an advantage
· Must be able to communicate and write clearly in English
· Must have excellent written and oral communication skills
· Attention to detail and overall drug application quality and internal consistency
· Strong interpersonal skills
· Ability to deliver against time-sensitive deadlines amid conflicting demands
· Proficiency in computer skills (Microsoft Office, eCTDmanager or equivalent)
