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Senior Associate, Global Regulatory Operations- 12

4 months ago

London, Greater London, United Kingdom Ultragenyx Pharmaceutical Full time

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_

Senior Associate, Regulatory Operations within the Global Regulatory Affairs Department. As a member of the Regulatory Operations team, this position formats and electronically prepares regulatory submission documents (e.g. clinical, nonclinical, safety and quality documents) for global fi lings ensuring adherence to company style, and compliance with regulatory guidance's. He/She will also prepare life-cycle submissions under supervision.

The scope of activities includes but is not limited to the following:

MS Word formatting, PDF bookmarking and hyperlinking, electronically compiling and archiving of regulatory submissions using publishing tools and in accordance with company standards.

This position requires a high degree of focus and consistent attention to detail.

Work Model:

Remote:

Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.


Responsibilities:

  • Performs moderately complex to nonroutine submission formatting activities associated with generating hard copy and electronic submissionready documents and reports.
  • Electronically compiles all components of moderately complex submissions using Lorenz DocuBridge and associated publishing tools including, but not limited to: eCTDs
  • National and Centralised Procedures; Post Marketing/Lifecycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
  • Dispatches submissions through the relevant gateways/portals (e.g. EMA Submissions Gateway and US Gateway and/or other channels) and electronically archives them according to the departmental practices.
  • Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
  • May interface with crossfunctional 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.
  • Identifies and records issues that require resolution prior to finalization and liaises with responsible author to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
  • Exercises judgment within welldefined procedures and practices to determine appropriate action.

Requirements:

  • BA or BS degree with 5+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred.
  • Strong experience with EU submissions, but also some experience with submissions in other regions (US, CA, ROW, etc.)
  • Experience in successfully working in a fastpaced environment with tight timelines, large deliverables.
  • Ability to manage multiple ongoing projects simultaneously.
  • Must have excellent verbal and written skills, very strong organizational and time management skills.
  • Must have a very strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
  • Should demonstrate flexibility and willingness to accommodate adhoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines as well as to work overtime in order to meet required timelines.
  • Must have a strong working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, ISIToolBox, eCTD validation software, Lorenz DocuBridge (or other eCTD submission publishing tools) and standard Office tools.
    #LI-CK1
    #LI-Remote

_Full Time employees across the globe enjoy a range of benefits, including, but not limited to:_
-
_Generous vacation time and public holidays observed by the company_
-
_Volunteer days_
-
_Long term incentive and Employee stock purchase plans or equivalent offerings_
-
_Employee wellbeing benefits_
-
_Fitness reimbursement_
-
_Tuition sponsoring_
-
_Professional development plans_
- _Benefits vary by region and country_

  • See our _CCPA Employee and Applicant Privacy Notice_._
  • See our _Privacy Policy_._