Project Manager, Regulatory Affairs

4 months ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time
Roles & Responsibilities

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)


Tell employers what skills you have

Leadership
Microsoft Office
FDA
Oral Communication Skills
Regulatory Compliance
Interpersonal Skills
Regulatory Affairs
Chemistry
Biology
Project Management
Attention to Detail
Publishing
Time Management skills
Content Writing
Product Development
Life Sciences
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