Global Regulatory Affairs Strategist for Late-Stage Development

6 days ago

Gentofte, Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time
Company Overview

Ascendis Pharma A/S is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark.

Salary and Benefits

The estimated salary for this position is between 120,000 - 180,000 DKK per year, depending on experience. In addition to the base salary, we offer a range of benefits including flexible working hours, the possibility to work partly from home, and access to a modern office facility in Tuborg Havn in Hellerup.

Job Description

We are seeking an experienced Regulatory Affairs CMC Associate Director to support our global strategy and drive regulatory activities for late-stage development. As a key member of our Regulatory Affairs team, you will be responsible for planning and driving regulatory activities and deliverables according to Ascendis business strategy and agreed timelines.

Your main responsibilities will include:

  • Understanding regulatory requirements and establishing a regulatory strategy for second-line marketing applications, global clinical trial applications, post-approval changes, and 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 liaising and negotiating with global regulatory authorities.
  • Managing new and pending IMPDs and INDs, as well as compassionate use programs.
  • Reviewing and approving regulatory documentation and response packages.
  • Building partnerships with key stakeholders from other functions and external partners to ensure strategic business goals are met through sharing knowledge and expertise.
  • Contributing to internal regulatory policies and procedures, developing best practices, and work processes.
Required Skills and Qualifications

To succeed in this role, you will need:

  • A Master's degree within Natural Science or a related field.
  • A proven record of broad regulatory experience and documented professional experience from a Regulatory Affairs CMC position in the pharma industry.
  • The ability to build trust and respect within the organization.
  • Strong collaboration and stakeholder management skills.
  • The ability to think creatively and develop solutions.
  • Excellent collaboration and communication skills.
  • Proficiency in English at a professional level, both written and spoken.
About Us

As a member of our global team, you will work closely together with Danish and US colleagues across Regulatory Affairs, CMC Development, Product Supply, Quality Assurance, and with our global partners. We offer flexibility in working hours and the possibility to work partly from home.

Location

You will be based in our modern office facility in Tuborg Havn in Hellerup, offering a view of the harbour, canals, and sea.

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