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Associate Director for Global Roll Out
1 month ago
We are seeking an experienced Regulatory Affairs CMC Associate Director to join our team at Ascendis Pharma A/S. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the global strategy of our company.
About the RoleThe successful candidate will be responsible for planning and driving regulatory activities and deliverables according to Ascendis business strategy and to agreed timelines. Key responsibilities include:
- Understanding regulatory requirements and establishing the regulatory strategy for submission of 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 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.
- Contributing to internal regulatory policies and procedures, to develop best practices and work processes.
The ideal candidate will have 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. Additionally, the candidate should possess strong collaboration and stakeholder management skills, think creatively, and develop innovative solutions. Proficiency in English at a professional level, both written and spoken, is also required.
About UsAscendis Pharma A/S is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark. We offer a collaborative and entrepreneurial work environment, with a short line of command. Our team is passionate about making products available for patients worldwide, and we are committed to advancing our exciting product pipeline.
What We OfferWe offer a competitive salary and benefits package, as well as opportunities for professional development and growth. Our team is dedicated to supporting each other's success, and we encourage collaboration and knowledge-sharing. If you are a motivated and experienced Regulatory Affairs CMC professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
