Pharmaceutical Product Expert

1 month ago


Gentofte, Gentofte Kommune, Denmark Ascendis Pharma AS Full time
Job Description

At Ascendis Pharma A/S, we are seeking a skilled Pharmaceutical Product Expert to join our team. This exciting opportunity will enable you to utilize your expertise in drug product manufacturing and regulatory requirements.

About the Role

We are looking for an experienced professional with a strong background in aseptic processing and regulatory affairs. As a Pharmaceutical Product Expert, you will be responsible for ensuring that our commercial drug products meet current legislation and approvals. Your primary tasks will include preparing regulatory documentation for submission in new countries, answering questions from health authorities, and reviewing colleagues' registration documentation.

You will also support manufacturing activities at contract manufacturing organizations (CMOs), including follow-up on deviations, changes, production metrics, continued process verification activities, and optimization projects. Additionally, you will facilitate inter-departmental communication and ensure effective handoffs to execute on important project milestones.

Required Skills and Qualifications
  • Relevant university degree in a field such as pharmacy, engineering, or sciences
  • 5-10 years of experience in drug product manufacturing and/or regulatory requirements
  • Experience in aseptic processing and regulatory affairs
  • Analytical mindset and ability to troubleshoot complex issues
  • Ability to manage details and ensure a holistic approach towards all steps in the manufacturing process
Benefits

As a Pharmaceutical Product Expert at Ascendis Pharma A/S, you can expect a competitive salary range of approximately $85,000 - $115,000 per annum, depending on your level of experience. You will also enjoy a dynamic and entrepreneurial work environment with opportunities for growth and development. Our office is located in Hellerup, Denmark, near the harbour and canals.



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