Global Regulatory CMC Director

17 hours ago


Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Key Responsibilities:

The successful candidate will be responsible for planning and driving regulatory activities and deliverables according to Ascendis Pharma's business strategy and to agreed timelines.


Key Deliverables:

  • Understanding the regulatory requirements and establish the regulatory strategy for submission of second line marketing applications, global clinical trial applications, post approval changes & 2nd generation development.
  • Planning, submission, and approval of applications in collaboration with our global partners.
  • Driving and coordinating preparation of meeting packages and response strategies to Health Authorities, and for liaising and negotiating with global regulatory authorities.
  • Managing new and pending IMPDs and INDs, and compassionate use programs.
  • Review and approval of regulatory documentation and response packages.
  • Build partnerships with key stakeholders from other functions and external partners to ensure that strategic business goals are met through sharing knowledge, and expertise.
  • Contribute to internal regulatory policies and procedures, to develop best practices and work processes.

Requirements:

The successful applicant preferably:



  • Holds a Master's degree within Natural Science or a related field.
  • Has a proven record of broad regulatory experience and documented professional experience from a Regulatory Affairs CMC position in the pharma industry.
  • Is highly committed to deliver outstanding results within the established timelines.
  • Has the ability to build trust and respect within the organization.
  • Possesses strong collaboration and stakeholder management skills.
  • Thinks creatively and develops creative solutions and has a hands-on attitude.
  • Possesses excellent collaboration and communication skills.
  • You are proficient in English at a professional level, both written and spoken.


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