Senior Manager, Global Regulatory Operations

Ascendis Pharma

Hellerup, Denmark

Description

Are you detail‑oriented, highly organized, and committed to quality? Do you thrive on creative problem‑solving and have hands‑on experience with eCTD publishing? If so, you may be the perfect fit for our next Senior Regulatory Operations Manager!

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.