PRESTIGE BIOPHARMA LTD | Project Manager, Regulatory Affairs
4 days ago
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)
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