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REGULATORY OPERATIONS SPECIALIST (F/M/D) FOCUS: VEEVA SYSTEM

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Offered by:

Bavarian Nordic GmbH

IT & Technology
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Would you like to join a dedicated global Regulators Affairs Team to ensure development and marketing authorisation of key vaccines within infectious diseases?Join our transformative journeyAt Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox vaccines and our commercial product portfolio contains market-leading vaccines against rabies and tick-borne encephalitis as well as an Ebola vaccine. Our late-stage pipeline comprises a novel COVID-19 vaccine for boosting existing immunity and a vaccine against respiratory syncytial virus (RSV), for which no approved vaccines exist today.We have embarked upon a transformative journey towards becoming one of the largest pure play vaccine companies by excelling in R&D innovation, manufacturing, and commercialization, and are looking for more talent to help drive the change. Come on board our journey and let’s change more lives, together.Our Regulatory Operations TeamOur overall Regulatory Affairs Department consists of about 20 enthusiastic experts and spans our international sites in Denmark, Germany, Switzerland and the USA. We cover RA development, RA CMC, RA lifecycle and maintenance as well as RA operations teams.We head up all submissions to international health authorities for Bavarian Nordics’ products, ensuring their access to and success on diverse markets. Become part of a dedicated team adapting their organization and processes to a growing company.About the job
  • Onboard and train users in Veeva RIM system as well as provide daily support for Veeva RIM and Veeva Quality to RA department and other functions
  • Support workflows (for RA team members) in Veeva RIM and provide information about all functionalities as well as documents from Veeva as needed
  • Responsible to track submissions/applications/reports/documents in Veeva RIM and to upload all HA correspondences
  • Provide regulatory support and advice to cross-functional team members as needed regarding systems, templates and formatting assistance for regulatory eCTD submission components
  • Coordinate, assemble and publish both major and routine global paper and electronic submissions (eCTD, eIND or non eCTD format), including MRP/DCP/CP, BLAs, INDs, CTAs/IMPDs, MAAs, NDS as well as life cycle management, annual reports, periodic safety reports, supplements, amendments, variations, renewals etc.
  • Publish and archive various metrics as well as the submission process to global health authorities (eCTD publishing and electronic document management system)
  • Responsible for IDMP project tasks 2022/23

About youYour qualifications

  • Ideally in-depth kledge and hands-on experience in Veeva RIM
  • Minimum of 2 years of experience in electronic document management (e.g. ERP systems such as SAGE, SAP or DB, Extedo eCTD Manager, SARA, Veeva RIM)
  • Basic kledge of regulations and industry standards regarding eCTD requirements and document formats/ standards
  • od written and verbal communication skills in English
  • Experience with EMA, FDA and Canada Health Experience would be an advantage
  • Commercial education with experience in life science sector or other relevant fields, alternatively a long-standing background in the healthcare industry is required
  • Ability to work according to deadlines

We offerA chance to work in an international company with unique technology and a dedicated work force. We offer a dynamic work environment and an opportunity to develop both your personal and academic competencies. Caught your interest?If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the -Button on the right side of the page and you will be redirected to our application form.We are interviewing on an ongoing basis.

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of live-saving vaccines. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Denmark and with operations in Germany, Switzerland and USA, the company employs more than 700 people. Bavarian Nordic is an Equal Opportunity Employer. Our culture expresses who we are, and how we interact and communicate with each other, our customers, partners, and shareholders. We call our culture ‘Our Bavarian Nordic DNA’ because it is at the heart of everything we do: PERSISTENT PIONEERS - EMBRACING CHANGE - BOOSTED BY THE TEAM - PROTECTING LIVES EVERY DAY

www.bavarian-nordic.com