Senior Regulatory Operations Manager at Ascendis Pharma

Gentofte Municipality, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Operations, Timeline Management, Quality Control, Electronic Publishing, Project Planning, Document Preparation, Regulatory Documentation, Communication Skills, Organizational Skills, Time Management, Microsoft Office Suite, Adobe Acrobat, Veeva Vault RIM, Detail-Oriented, Problem-Solving, Team Collaboration

Industry

Biotechnology Research

Description

Are you detail-oriented, structured, and quality-minded? Do you enjoy creative problem-solving? If so, you may be 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 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 8 years of directly relevant regulatory operations experience in the pharmaceutical and/or biotechnology industries, or a minimum of 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), Word Templates, and regulatory document publishing tools (Adobe Acrobat, ISI Toolbox). Prior experience with an EDMS; 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 30days 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 at+1(650)665-3459 or adn@ascendispharma.com or visit our website www.ascendispharma.com (www.ascendispharma.us 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.

Responsibilities

You will manage daily operational activities for regulatory submissions, ensuring compliance with agency requirements. This includes leading electronic publishing efforts and collaborating with cross-functional teams to create submission project plans.