Senior Regulatory Affairs Project Manager

4 days ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time

We are seeking a highly skilled and experienced Senior Regulatory Affairs Project Manager to join our team at Prestige Biopharma Limited.

About the Role

This is an exciting opportunity for a motivated individual to lead regulatory project submissions, manage key projects, and collaborate with stakeholders to ensure project timelines are met.

As a Senior Regulatory Affairs Project Manager, you will be responsible for reviewing, preparing, and authoring documents for regulatory submissions, monitoring progress of applications, and providing regulatory input and recommendations for product development.

You will work closely with relevant stakeholders to ensure that project deadlines are met and that regulatory compliance is maintained.

Requirements
  • Bachelor's degree in chemistry, biology, or a 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 be advantageous;
  • Excellent written and oral communication skills in English;
  • Attention to detail and strong interpersonal skills;
  • Ability to deliver against time-sensitive deadlines amid conflicting demands;
  • Proficiency in computer skills (Microsoft Office, eCTDmanager or equivalent).
Estimated Salary

The estimated annual salary for this role is £55,000 - £65,000 depending on location and experience.

Benefits

We offer a comprehensive benefits package including a competitive salary, pension scheme, and opportunities for professional development.



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