Sr. Manager Regulatory Operations
Do you have an eye for detail, structure and a good quality mindset? Are you creative at problem solving?
If so, now is your chance to join Ascendis Pharma as our new Senior Regulatory Operations Manager.
Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.
We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.
We are seeking a passionate 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 assisting with the daily operational activities for regulatory submissions, timeline management and archival activities in accordance 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 5 colleagues based in Denmark and the U.S., and report directly to Anaia Davidson, Director Regulatory Operationswho is based in Palo Alto, California. You will be based in Hellerup.
Your key responsibilities will be:
- Managing daily operational activities for preparation of regulatory submissions (timeline management, scheduling, formatting, publishing, QC, archive, and submission).
- Leading electronic publishing efforts in support of electronic submission of Investigational and Marketing applications to Health Authority Agencies worldwide, as required.
- Collaborating with Regulatory Affairs and contributing functional areas to create submission project plans, trackers, and timelines for assigned projects.
- Preparing documents in all disciplines (e.g., CMC, nonclinical, clinical, and regulatory) to meet applicable standards for submissions in eCTD format and or paper submission, when required.
- Supporting the use of templates and guidelines for documentation to be included in regulatory submissions; Provide formatting assistance and training to cross-functional team members, as needed.
- Providing expertise in regulatory and technical submission requirements regarding submission preparation, format, and structure.
- Providing 1st tier support for Veeva RIM system.
Qualifications and Skills:
You hold a relevant academic degree and 6 years of experience performing directly relevant regulatory operations activities in the pharmaceutical and/or biotechnology industries, OR at least 8 years of experience performing directly relevant regulatory operations activities in the pharmaceutical and/or biotechnology industries. You are proficient in English at a professional level, both written and spoken.
Furthermore, you have:
- Thorough working knowledge of evolving technical requirements for electronic EU, Canadian and US Investigational and Marketing submissions.
- Advance proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project), Word Templates and publishing regulatory documents using Adobe Acrobat and ISI Toolbox.
- Prior experience with an EDMS required. Experience with using Veeva Vault RIM preferred.
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 possess strong communication, organizational, planning, and time-management skills.
Travel: up to 20 – 30days per year.
Office: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
Applications will be evaluated when received, so please apply as soon as possible.
All applications must be submitted in English and are treated confidentially.