Regulatory Affairs Project Lead

4 days ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time
About the Role

Prestige Biopharma Limited seeks an experienced Regulatory Affairs Project Lead to join our team. This exciting opportunity will enable you to utilize your expertise in managing regulatory submissions, executing projects, and maintaining compliance.

Key Responsibilities:
  • Manage project submissions as assigned by leadership, ensuring timely execution and successful approval.
  • Support the management of key projects, including submission, approval, and launch, while collaborating with stakeholders.
  • Review, prepare, and author documents for regulatory submissions, including clinical trial applications and marketing authorization applications.
  • Maintain knowledge of current regulations to ensure regulatory compliance and provide recommendations for product development.
  • Monitor progress of applications submitted to regulatory authorities and communicate effectively with relevant stakeholders.
Requirements:
  • A 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, with proficiency in Microsoft Office and eCTDmanager or equivalent.
What We Offer:
  • A competitive salary range: £60,000 - £80,000 per annum, depending on experience.
  • An attractive benefits package, including pension scheme, healthcare insurance, and generous holiday allowance.
  • Ongoing professional development opportunities and training.
  • The chance to work with a dynamic team in a rapidly growing industry.
About Us:

Prestige Biopharma Limited is a leading biopharmaceutical company committed to delivering innovative solutions that improve patient outcomes. Our mission is to pioneer new treatments and therapies, while prioritizing regulatory compliance and excellence in every aspect of our operations.



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