Global Regulatory Affairs Director
23 hours ago
At Ascendis Pharma A/S, we are seeking an experienced and skilled Global Regulatory Affairs Director to join our dynamic team. With a focus on innovation and patient care, we strive to make a meaningful difference in the lives of patients worldwide.
Job SummaryWe are looking for a seasoned professional with a proven track record in regulatory affairs to lead our global regulatory strategy and initiatives. As a key member of our team, you will be responsible for driving regulatory activities and deliverables that align with our business strategy and objectives.
Key Responsibilities- Develop and implement global regulatory strategies to support second-line marketing applications, clinical trials, and post-approval changes.
- Collaborate with global partners to plan, submit, and obtain approvals for regulatory applications.
- Coordinate preparation of meeting packages and response strategies for Health Authorities and liaise with global regulatory authorities.
- Manage new and pending IMPDs and INDs, as well as compassionate use programs.
- Review and approve 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.
- 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.
- Excellent communication and problem-solving skills.
- You are proficient in English at a professional level, both written and spoken.
We offer a competitive salary of approximately $120,000 per year, based on the location and industry standards. Additionally, you will have the opportunity to work in a modern office facility in Tuborg Havn, Hellerup, with a view of the harbour, canals, and sea. We also offer flexibility in working hours and the possibility to work partly from home.
About UsAscendis Pharma A/S is a fast-growing, dynamic biopharmaceutical company with headquarters in Denmark. We are committed to advancing our product pipeline and making a meaningful difference in the lives of patients worldwide.
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