Associate Director for Global Roll Out - Regulatory Affairs CMC

Ascendis Pharma

Hellerup, Denmark

Description

Do you want to work globally in an innovative company making products available for patients worldwide?

We offer you an exciting and challenging position in an entrepreneurial and international company, with a short line of command. As our new Associate Director, you will be responsible for activities that are central to Ascendis Pharma’s global strategy, and you will work cross functionally to identify the best regulatory opportunities for bringing a new product to the patients.

We are looking for an experienced Regulatory Affairs CMC (RA CMC) Associate Director, who will be responsible for RA CMC strategy support to second line regulatory approvals, as well as development and life cycle activities for a product that recently obtained first market approval in late-stage development. You will also be involved in building up our internal standards and processes in support of global regulatory activities.

You will be responsible for planning and driving regulatory activities and deliverables according to Ascendis business strategy and to agreed timelines. You will be the overall accountable for specific deliverables such as:

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.

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;
Another essential factor to succeed in this role is your ability to contribute to the teamwork culture, provide support and share knowledge with your colleagues.

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