Senior Manager, Global Regulatory Operations
Ascendis Pharma
full-time
Posted on:
Location Type: Hybrid
Location: Hellerup • 🇩🇰 Denmark
Visit company websiteJob Level
Senior
Tech Stack
Vault
About the role
- 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.
Requirements
- 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.
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionstimeline managementquality controldocument preparationelectronic publishingregulatory documentationtechnical submission requirementsEDMSVeeva Vault RIMregulatory operations experience
Soft skills
communicationorganizational skillsplanningtime-managementdetail-orientedteam-orientedability to manage multiple prioritiesability to thrive in fast-paced environment