Sr. Manager, RA Labelling

Gentofte Kommune - Denmark

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Regulatory Affairs

Job Summary

Description

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 global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in 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 bachelors 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.

Travel: 5 - 10 days per year.

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 .

You can learn more about Ascendis by visiting our website

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

A note torecruiters:

Wedo notallowexternalsearchparty ofcandidateswithoutwrittenpermission from the Ascendis PharmaHR team(specificallyfrom: TalentAcquisitionPartner or Human ResourcesDirector) is .

Required Experience:

Manager

DescriptionAre you passionate about labeling and related processes Do you have experience with the EMA centralized procedure for medicinal productsIf so now is your chance to join Ascendis Pharma as our new Manager/senior Manager.Ascendis Pharma is a global biopharmaceutical company committed to mak...