Senior Regulatory Affairs Director for Global Strategy
17 hours ago
Embark on an exciting career opportunity with Ascendis Pharma A/S, a fast-growing dynamic biopharmaceutical company. As our new Senior Regulatory Affairs Director for Global Strategy, you will play a pivotal role in driving the company's global strategy forward.
Job Description:As a member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to support the company's global growth ambitions. Your primary focus will be on planning and executing regulatory activities and deliverables according to the company's business strategy and agreed timelines.
Key responsibilities include:
• Developing and implementing regulatory strategies to support the company's global growth ambitions.
• Planning, submission, and approval of applications in collaboration with 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.
• Building partnerships with key stakeholders from other functions and external partners to ensure that strategic business goals are met through sharing knowledge, and expertise.
The ideal candidate will have a strong background in regulatory affairs, preferably with experience in a similar role in the pharmaceutical industry. You will be highly committed to delivering outstanding results within established timelines and possess excellent collaboration and communication skills.
As our Senior Regulatory Affairs Director for Global Strategy, you will work closely with Danish and US colleagues across Regulatory Affairs, CMC Development, Product Supply, Quality Assurance, and with our global partners. You will be part of a well-established and team-oriented department, currently consisting of experienced and dedicated colleagues who actively share learnings and experience.
We offer flexibility in working hours and the possibility to work partly from home. You will have many internal and external stakeholder interactions, and we will actively support your professional development by providing appropriate training, hands-on experience, and the opportunity to learn from experienced colleagues.
The successful applicant will be able to contribute to the teamwork culture, provide support and share knowledge with colleagues. If you are passionate about regulatory affairs and eager to take on a challenging role in a dynamic biopharmaceutical company, please submit your application with your CV and responses to the following questions:
• Why do you apply for this position?
• How will your personal and regulatory skills provide value to Ascendis?
• What do you expect from your colleagues?
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