Manager/Associate Director Regulatory Affairs
Ascendis Pharma, Denmark

Manager/Associate Director Regulatory Affairs

Join theGlobal Regulatory team in a leading and fast-growing biotech company

Ascendis Pharma is looking for a new colleague to join the Regulatory Affairs team as Manager/Associate Director

You will be part of the teams driving Ascendis’ projects further and ensure the best progress of your designated projects. You will be responsible for operational regulatory input as well as implementing regulatory strategies across Non-clinical and Clinical in collaboration with the rest of the regulatory team.

Main areas of responsibility:

• Participating in the development and implementation of regulatory strategy for specific programs
• Providing strategic and tactical regulatory contributions to global development plans
• Planning and coordinating aspects of regulatory submissions necessary to support all types of regulatory applications - clinical trial applications, marketing authorizations, variations/post-approval changes, a.o.
• Effectively working in a team environment with collaborations across locations and departments including writing and supporting regulatory communications
• Supporting the company through regulatory intelligence efforts and contribute to internal regulatory policies and procedures to achieve best practices

Criteria of success in the role will be to build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise, and the provision of appropriate resources.

You hold a university degree within Natural Science or a related field.

You have at least 8-10 years of documented professional experience from a Regulatory Affairs position in the Pharma industry. You are able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders. You are pragmatic, flexible and solution-oriented.

You are proficient in English at a professional level, both written and spoken, and you master MS Office.

You are a highly motivated individual who enjoys being challenged and working in a collaborative environments. You are passionate about creating a sustainable footprint rather than building a career. However, Ascendis Pharma is growing rapidly, as will Regulatory Affairs, and there will be opportunities as the organization develops.

Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.

Travelling: 10-15 days per year.

Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbour, the canals, and the sea.

For more details about the job or the company, please contact Katarina Jelic Maiboe at . All applications must be submitted in English and are treated confidentially.

Application will be evaluated when received, so please apply as soon as possible.

Job Rewards and Benefits