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Senior Regulatory Submission Manager - Study Start- up (m/f/x)

  • Location: Schwandorf in Bayern
  • Salary: package negotiable per year
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Pharmaceutical
  • Contact: Marlene Inderhees
  • Contact Email:
  • Expiry Date: 24 March 2023
  • Job Ref: 22_2023_1677062133

Senior Regulatory Submission Manager (m/f/x) - Study Start-up | Bavarian | CRO

Our client is a CRO who provide in Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical devices industries. The mission is to expedite the global discovery of safe and potent medical therapeutics through a scientifically disciplined focus. Our client is currently growing fast in clinical submissions and is currently looking for a full time Regulatory Submissions Manager to join.

We are looking for a dynamic and driven personality to join the clinical operations team. The Position is a key role in the clinical trail management process at the company. Our client welcomes you to be part of something that will impact millions of people around the world, while benefiting from a highly competitive total rewards and performance package and internal growth opportunities.

What will your tasks as Senior Regulatory Submission Manager - Study Start -up be?

  • Efficient management and successful delivery of all facets of global start-up in line with the client's specifications;
  • Prepare and approve contract statements
  • Implement quality control of submission documents and site key documents
  • Presenting at proposal advocacy meetings, general capabilities meetings and audits
  • Prepare and approve contract statements
  • Responsible for EU / EMEA countries to sponsors.
  • Accountable for the trial in front of the sponsors

Your requirements?

  • At least 4 years of experience in clinical research (prefer CRO)
  • Experience in project management
  • depth knowledge with clinical trail applications in Europe

Essential knowledge & skills:

  • Very good written and spoken English; knowledge of German and other languages is an advantage
  • Reliability, team spirit, initiative, cross-departmental thinking and the ability to manage several projects simultaneously

What does the position of Senior Regulatory Submission Manager - Study Start -up offer you?

  • Salary: base salary + year bonus
  • 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
  • Homeoffice: after probation time - 8 day per month + 10 days additionally per year
  • This is a Headquarter position and needs regular presence on site!
  • Location: Munich or various others

My contact details:

  • Email:
  • Tel: 0049 (0) 89/26 20 09 25 (direct dial)
  • Xing:
  • LinkedIn:

I look forward to your application!