Sr. Manager, RA Labelling

Are you passionate about labeling and related processes? Do you have experience with the EMA centralized procedure for medicinal products?

If so, now is your chance to join Ascendis Pharma as our new Manager/senior Manager.

Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs.

Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets.

We are seeking a passionate colleague to join our growing team. As a key member of the team, you will play a crucial role in handling labelling updates and further develop our internal labeling processes. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the RA Clinical Strategy Team consisting of 9 colleagues, and report directly to Mette Schou-Hanssen, Senior Director. You will be based in Hellerup.

Your key responsibilities will be:

• Managing activities related to labelling for our approved products, primarily with EU focus
• Develop and maintain our labeling processes together with a dedicated team
• Oversight of label requirements with focus on EU regulation

Qualifications and Skills:

You hold a relevant bachelor’s degree or are educated as a pharmaconomist – and have 5 years of experience within Regulatory Affairs in the Pharma Industry.

Furthermore, you have experience:

• In working with the QRD template and the Centralized Procedure
• With EU guidance and processes related to the above
• Working with eCTD
• In writing SOPs and Work Instructions
• Veeva experience will be a plus

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to be accurate, structured, and a clear and concise communicator.

Office: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn, Hellerup.

Apply now.

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

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company, please contact Mette Schou-Hanssen, Senior Director, mhn@ascendispharma.com.

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications submitted via email or other channels will not be reviewed.