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Senior Manager/Associate Director Regulatory Affairs

Join an entrepreneurial and fast-growing company where skilled, agile and highly resourceful professionals can truly make their mark.

 

As Senior Manager/Associate Director Regulatory Affairs at Ascendis Pharma you will be a part of the different teams driving Ascendis’ development projects further. You will be a key member of the Regulatory Affairs team and provide effective support to the organization to ensure the best development programs for your designated projects. You will be responsible for operational regulatory input across CMC, Non-clinical and Clinical in collaboration with the rest of the RA team.

The position will report to the Senior Director, Regulatory Affairs, DK.

Your main tasks are:

  • Support of INDs and clinical trial applications, NDA/BLAs, MAA and other regulatory documents as needed
  • Collaborate in project teams with e.g. scientific advice preparation, orphan drug designation applications and paediatric investigation plans including writing and supporting regulatory communications
  • Contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes including writing of SOPs
  • Stay abreast of newly issued regulatory laws and guidance as well as technical publications, articles, and abstracts to promptly identify possible impact or improvements to product programs incl. regulatory newsletter

You must have a university degree in natural science or a related field, and you have at least five years of documented professional experience from a regulatory affairs position in the pharma industry. If you have experience interacting directly with regulatory authorities on an international scale, that is a plus. This position requires someone who considers his or her background as that of a generalist and who is comfortable in a variety of disciplines including CMC, Clinical, and Non-clinical areas. Dossier preparation experience in the US and the EU is a plus.

You will collaborate with colleagues in Denmark, Germany and US, so excellent people collaboration and communication skills are very important. Furthermore, you must be able to work well independently for the success of your projects, appreciating portfolio priorities. You must be highly committed to delivering outstanding results at all times. You must be an adaptable and robust person with a hands-on attitude.

You are proficient in English at a professional level both written and spoken and you master MS Office. Experience with MS Projects or other project tools are an advantage.

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 Tuborg Havn in Hellerup.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M +45 21 75 19 25 or Senior Research Consultant, Anne Thomsen on M +45 31 40 01 11. All applications must be submitted in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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