(Senior) Expert Regulatory Affairs CMC - FDA Focus (m/f/x)

(Senior) Expert Regulatory Affairs CMC - FDA Focus (m/f/x)

Job Title: (Senior) Expert Regulatory Affairs CMC - FDA Focus (m/f/x)
Contract Type: Permanent
Location: Ulm, Baden-Württemberg
Salary: negotiable
Start Date: ASAP
Reference: RA_2021_01_1610527939
Contact Name: Sebastian Gotzler
Contact Email:
Job Published: January 13, 2021 08:52

Job Description

(Senior) Expert Regulatory Affairs CMC - FDA Focus (m/f/x) | Ulm / remote | Pharma

Your ambition is to get to know regulatory affairs "out the box" and to exercise it holistically? You like a very dynamic and innovative atmosphere in a well-supported startup environment? Do you not only work strictly according to job description and feel well looked after in an agile environment? You have a proactive mindset and see great potential for your career in times of company growth?

If you are interested in experiencing this at a very well-positioned and innovative quantum technology startup, then you have come to the right place!

What will your activities as (Senior) Expert Regulatory Affairs CMC - FDA Focus involve?

  • Develop and implement global regulatory strategies for sterile pharmaceutical products, including proactive identification of regulatory risks / options and mitigation strategies
  • Write and review of regulatory documents required for filing of IND/CTAs; including but not limited to CMC Modules, Product Information, responses to the Health Authority questions, clinical study protocols and reports, investigator's brochures, case report forms, informed consent forms and other relevant documents
  • Prepare and review briefing documents for Health Authority meetings
  • Contribute to regulatory due diligence of the preclinical and early clinical data in support of early development projects
  • Support development of Target Product Profile for assigned development projects
  • Monitor changes in the regulatory environments and advise on company adaptive responses

What does this position offer you?

  • Salary: very attractive salary package
  • Contract type: unlimited
  • Vacation: 30 days / year
  • Working time: 40 hours / week
  • Accessibility: Very good transport connections by public transport; sufficient parking spaces available
  • Start date: At the next possible date
  • Location: On-site in Ulm or up to 80% remote with ad-hoc travelling to Ulm

What requirements should you bring along?

  • Ph.D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • At least 8 years' experience in a hands-on Regulatory affairs CMC position for pharmaceutical drugs
  • 5 years' experience in an early-stage development environment
  • Experience with QA methods / documentation
  • Experience in Working with IND submissions
  • Very good knowledge of FDA Guidelines
  • Excellent written and verbal communication skills in English
  • Excellent communication and presentation skills
  • Very good comprehension, independent way of working, intercultural competence

Information about our customer:

Our client is an innovative quantum technology startup that was founded as a spin-off from Ulm University and is supported by leading investors from Silicon Valley and Europe. Their mission is to use their unique know-how in the field of quantum technology to become a driving force in the development and commercialization of novel methods of medical imaging. They are planning to almost double their size of employees over the next year (from 30 to over 50).

Does this position sound interesting to you? Then you should apply now! If you would like to receive further or alternative positions, I would also be pleased to receive your application!

I look forward to your application!