Senior Manager, Global Regulatory Operations
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Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Are you detailoriented highly organized and committed to quality Do you thrive on creative problemsolving and have handson experience with eCTD publishing If so you may be the perfect fit for our next Senior Regulatory Operations 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 a Senior Regulatory Operations Manager to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in As a key member of the Ascendis Pharma team you will play a crucial role in overseeing daily operational activities related to regulatory submissions timeline management and archival processes ensuring compliance with agency requirements and company standards. 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 Global Regulatory Operations team consisting of 8 colleagues located in both Denmark and the US and will report directly to Anaia Davidson Senior Director Global Regulatory Operations who is based in the US. The position is based in Hellerup
You will be responsible for:
- Managing daily operational activities for regulatory submissions including timeline management scheduling formatting publishing quality control archiving and submission to Health Authorities.
- Leading electronic publishing efforts for Investigational and Marketing applications to Health Authority Agencies worldwide.
- Collaborating with Global Regulatory Affairs and other functional areas to create submission project plans trackers and timelines.
- Preparing documents across all disciplines (e.g. CMC nonclinical clinical regulatory) to meet global standards for electronic submissions.
- Supporting the use of templates and guidelines for regulatory documentation; provide formatting assistance and training to cross-functional team members as needed.
- Providing expertise in regulatory and technical submission requirements including preparation format and structure.
- Serving as first-tier support for the Veeva RIM system.
Your professional qualifications
Academic degree and at least 6-8 years of directly relevant regulatory operations experience in the pharmaceutical and/or biotechnology industries or a minimum of 8-10 years of directly relevant regulatory operations experience within a pharmaceutical and/or biotechnology company.
Furthermore you have:
- Thorough knowledge of technical requirements for electronic EU Canadian and US Investigational and Marketing submissions.
- Strong communication organizational planning and time-management skills.
- Professional proficiency in English both written and spoken.
- Detail-oriented with the ability to thrive in a fast-paced team-oriented small company environment managing multiple priorities and deadlines.
- Advanced proficiency with Microsoft Office Suite (Word Excel PowerPoint Project)and Word Templates
- Demonstrated proficiency in eCTD publishing electronic submission platforms Adobe Acrobat TRX Toolbox and related publishing tools.
- Prior experience with regulatory information management systems (RIMS); experience with Veeva Vault RIM is preferred.
As a person you are:
- Detail-oriented with a strong quality mindset.
- Results-driven and committed.
- Flexible adaptable and a self-starter.
- Able to manage multiple tasks and projects simultaneously.
Travel: Ability to travel up to 30 days per year.
Office location:Ascendis Pharma resides in Tuborg Havn Hellerup
Apply now.
We evaluate applications when received so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed please submit it through the specified platform - applications sent by email or other channels will not be evaluated
For more details about the position or the company please Anaia Davidson Sr. Director Global Regulatory Affairs Operations at1 or or visit our website ( for US job ads) All applications must be submitted in English and are treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.
Required Experience:
Senior Manager
Key Skills
- Employee Evaluation
- Continuous Improvement
- FDA Regulations
- Management Experience
- Process Improvement
- Profit & Loss
- Operations Management
- Project Management
- Strategic Planning
- Leadership Experience
- P&L Management
- Supervising Experience
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
