Life Scientist as Team Leader - Management Regulatory Operations, Regulatory Affairs, eCTD Applications (m/f/d)

Join Bavarian Nordic and take a step into the future of vaccines. Our goal is to develop innovative and safe therapies against cancer and infectious diseases to improve the health and quality of life for children and adults.

To strengthen the Regulatory Affairs Department in Martinsried/Munich, we are searching for a qualified

Manager Regulatory Operations (f/m/d)

Your tasks

  • Provide strategic oversight and hands-on support for the planning, preparation, tracking, publishing and timely submission of global eCTD applications (e.g. IND, CTA, BLA, MAA, post-authorisation life-cycle management)
  • Lead the development and implementation of standards for publishing, archiving, metrics and submission process to global health authorities (eCTD publishing and electronic document management system)
  • Manage Bavarian Nordic’s Regulatory Operations team
  • Manage standardization of submission formats and coordination of alignment within the company
  • Maintain up-to-date knowledge of applicable regulations
  • Support artwork process

Your Profile

  • University degree (at least BSc or equivalent) in sciences
  • At least 5 years of experience in Regulatory Affairs, with at least 3 years of experience in Regulatory Operations
  • Ideally 2 years of managerial experience
  • Experience with eCTD publishing systems and electronic document management systems
  • Excellent knowledge of regulations and industry standards regarding eCTD requirements and document formats/ standards
  • Very good written and verbal communication skills in English
  • Ability to effectively work according to deadlines
  • Excellent interpersonal skills, ability to work as a member of a team and independently

Your Prospect

  • An exciting position in Regulatory Affairs department within an international environment
  • Working in a highly motivated team
  • Broadening your experience in an internationally operating, biopharmaceutical company

Contact

If you are interested in the position, we look forward to receiving your application in English with your annual salary expectations and your earliest possible start date via our internal system.

Just click here or click "APPLY" on the top right side of the page and you will be redirected to our application site.

We kindly ask recruitment agencies/headhunters to refrain from contacting Bavarian Nordic GmbH. Unsolicited documents will not be considered.

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. 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 Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

While applying for the job please refer to jobvector and use the following reference number: 100465

About Bavarian Nordic GmbH

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.
More about Bavarian Nordic GmbH