Global Regulatory CMC Director
17 hours ago
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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