EXTEDO is the key software and service solutions provider in the field of Regulatory Information Management (RIM). We offer configurable off-the-shelf products as well as customized and integrated solutions. EXTEDO's enabling technology, the EXTEDOsuite, is unique in all that it covers within Regulatory Affairs including: eCTD submission management, pharmacovigilance or drug safety management and product registration planning & tracking. EXTEDO serves over 700 Life Sciences customers, both large and small, in 60 countries, including the EMA and over 25 regulatory authorities worldwide. The areas of Life Sciences in which Extedo operates are: pharmaceuticals, biotech and biopharma, generics, medical devices, healthcare and the public sector. We are still growing!

For our location in Ottobrunn near Munich we are actively seeking a

 

Product Manager Regulatory Management and eSubmission (m/f)

Your Tasks - as important as our Software:

 
  • You will gain insight into market demands (via customer and internal stakeholder feedback).
  • be responsible for defining, maintaining and communicating the product vision as well as the product strategy.
  • be the voice of your product by positioning and promoting your product externally as well as internally.
  • actively listen to industry pains as well as scanning the horizon for future demands, changes that could impact the product strategy and vision.
  • provide assistance to the pre-sales and support teams.
  • define use-case oriented product requirements in collaboration with requirements engineering.
  • ensure professional implementation of the requirements together with our development unit.
  • be part of the scrum team as a product owner.

Your Profile - as good as our Solutions:

 
  • You have experience in the area of life sciences – ideally involving regulatory affairs, regulatory operations and regulatory processes.
  • a passion for working in a unique role where you can combine science and technology.
  • awareness and know-how in eCTD, IDMP and E2B (R2),
  • a university degree, e.g. in pharmacy, business management or information systems,
  • previously worked in the field of product management.
  • a goal-oriented business approach and an ability to assert yourself.
  • excellent planning and organizational skills and the capacity to deal with stress.

You will perform your tasks by collaborating with our product development, marketing, sales and consulting departments.
Additionally, you are an open-minded, team-oriented person with a strong desire to learn. You always strive for high quality outcomes and are a reliable and self-motivated individual. Lastly, you possess excellent English and preferable German language skills as well as a willingness to successfully conduct business in a multinational setting.