Junior Expert Drug Regulatory Affairs (m/w/d)

Posted:
10/21/2024, 3:51:38 AM

Location(s):
Hesse, Germany ⋅ Bad Homburg vor der Höhe, Hesse, Germany

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Legal & Compliance

Workplace Type:
Remote

Are you ready to make a significant impact in the ever-evolving medical technology industry? As a Junior Expert in Drug Regulatory Affairs, you'll play a crucial role in ensuring that cutting-edge medical products meet regulatory standards across global markets. This position offers you the opportunity to collaborate with multiple departments—such as Quality Control, Manufacturing, and Clinical Research—while honing your expertise in regulatory processes, dossier preparation, and compliance. If you're driven by precision, passionate about healthcare innovation, and eager to contribute to global health solutions, this is the perfect role for you.

Your tasks:

  • Support and preparation of approval dossiers in accordance with country-specific requirements
  • Updating the marketing authorization dossiers
  • Support in the processing of deficiency notifications and change notifications worldwide
  • Support in Creation, review and approval of product information texts
  • Support in the implementation of approval requirements in the Quality Control, Manufacturing, Quality Assurance and Clinical Research departments

Your profile:

  • Completed bachelor's degree (e.g. pharmacy, human medicine, natural sciences) or similar
  • Some initial professional experience is required to successfully take on the role
  • To successfully fulfill this role, a foundation of prior professional experience is essential
  • Ability to set and change priorities appropriately or to meet conflicting requirements
  • Quality-conscious, systematic and results-oriented way of working
  • Good knowledge of English (spoken and written)

Our offer for you:

There is a lot you can discover at Fresenius because we have a lot to offer. No matter what field you are an expert in and how much experience you have - for your professional future with meaning:

  • The opportunity to work remotely
  • Whether in front of or behind the scenes - you will help to make better medicine accessible to more and more people around the world
  • Individual opportunities for self-determined career planning and professional development
  • A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
  • A large number of committed people with a wide range of skills, talents and experience
  • The benefits of a successful global corporation with the collegial culture of a medium-sized company

Fresenius Medical Care North America

Website: https://fmcna.com/

Headquarter Location: Waltham, Massachusetts, United States

Employee Count: 10001+

Year Founded: 1996

Last Funding Type: Post-IPO Equity

Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical