Manager, Regulatory Operations Emea
vor 6 Monaten
**Why Join Us?**
- Be a hero for our rare disease patients_
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team
_. _
**Position Summary**:
**_ ultra_**_focused - Work together to fearlessly uncover new possibilities_
Ultragenyx is seeking a highly motivated individual for the role of a Manager, Regulatory Operations within the Global Regulatory Affairs Department, based in Regional European Headquarters in Basel, Switzerland.
This position will be responsible for managing all operational aspects of preparing compliant submissions irrespective of format to Health Authorities worldwide, with a primary focus on overseeing and accomplishing submissions for the Ultragenyx portfolio in EMEA (Europe, Middle East, Africa) region and providing support for other regions (US, CA, ROW). The Regulatory Operations Manager will provide expert technical guidance within the company on use of templates, MS Word, and other authoring tools to support regulatory submission activities. You will also provide leadership for publishing initiatives and oversee archiving of regulatory submissions, regulatory correspondence, and controlled documents.
**Work Model**:
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
**Responsibilities**:
- Coordinates and electronically compiles all components of Regulatory Agency submissions including, but not limited to: eCTDs - National and Centralized Procedures; Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
- Provides support to Regulatory team in preparation of submission-ready electronic documents utilizing industry-standard authoring, document management and publishing tools to ensure electronic submissions meet all required standards and technical requirements within specified timelines. This would be both with regard to Word format (use of relevant templates, formatting, insertion of Word hyperlinks, etc.) and PDFs (using Adobe Acrobat and ISIToolbox).
- Contributes to overall planning activities for submission timelines in accordance with project plans and the GRO Project Manager. Maintains and provides submission publishing tracking information and informs overall Submission Manager and project team on real time status of business-critical submissions.
- Provide support to RIM System Manager on Veeva Vault user support for members of Ultragenyx who contribute documents for submissions to competent authorities.
- Participates in supporting and promoting current initiatives in moving the company forward with electronic submissions and electronic archives and good document management principals.
- May interface with cross-functional teams and/or content authors to discuss routine submission preparation and content. May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures. Actively collaborates with Regulatory Operations colleagues to load balance submission activities to gain efficiencies.
**Requirements**:
- BA or BS degree with minimum of 5 years of proven experience in a Regulatory Operations role within the pharmaceutical or biotech industry, or an equivalent combination of education and experience.
- Excellent Microsoft Office (Word, Excel, PowerPoint), ISI Toolbox, and Adobe Acrobat. Expert level submission publishing skills and proven experience with industry publishing tools (Lorenz DocuBridge experience preferred).
- Current and very strong working knowledge of electronic document and submission standards and requirements (CTD/eCTD structure) applicable to the EU, US and global regulatory environments. Fundamental understanding of global regulatory guidance's in the EU, as well as US, Canada and rest of world.
- Must demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing priorities and deadlines in order to meet required timelines.
- Attention to detail: accurate and meticulous with an ability to detect and correct formatting errors/inconsistencies in documents and submissions.
- Proven ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills)
- Ability to manage multi
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