Regulatory Affairs Study Start Up Specialist

Highly Competitive
  1. Permanent
  2. Clinical Scientist
  3. Germany
Ulm, Baden-Württemberg
Posting date: 11 Feb 2019

ProClinical is advertising a new Regulatory Affairs Study Start Up Specialist position. This role is with an international CRO that prides itself in delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development. ProClinical is pleased to announce this vacancy, which is based in this company's Germany-based office.

Job Responsibilities:

  • Performing central and local IRB/IEC and Competent Authority (CA) submissions, according to different National Drug Laws on behalf of Sponsors and sites.
  • Preparing and/or carrying out a Quality Check of Clinical Trial Application forms (CTA, XML).
  • Receiving and processing study documentation from the sites, assessing accuracy and completeness.
  • Interacting with site personnel for document corrections, clarification, or resolutions of any incomplete/incorrect documentation, and filing any incomplete and inaccurate documents as drafts.
  • Accurately logging, tracking, and filing all correct and complete Study documentation in Trial Master File (TMF) of the study.
  • Interacting with Sponsors and forwarding regulatory documentation to Sponsors according to company Standard Operating Procedures (SOPs) or Sponsor Project-Specific Standard Operating Procedures (PSOPs).
  • Attending internal and external Study meetings and providing Regulatory status reports.
  • Performing and compiling all required documentations for submission to IRB/IEC (central and local) and to the CA.
  • Assessing accuracy and completeness of submitted documents) paper-based and/or electronic); performing quality control review before shipping documents to IRBs/IECs, and Cas.
  • Preparing submissions to IRB/IEC and/or Cas (First Submission, Substantial Amendments (Protocol-related and for notification only), notifying additional sub-Investigators, Shipping Annual Safety Reports, revising IBs, and IMPDs.
  • Responding to Deficiency Letters after interacting with Sponsors.
  • Instructing and supervising translation of regulatory documents, such as cover letters, deficiency letters, response letters, etc, on behalf of Sponsors as greed to in the scope.
  • Filing copies of submission packages in TMF (paper-based) and electronically on the company's study drive and/or Sponsor's SharePoint.
  • Communicating submission status to company study teams and/or Sponsor via Project Manager.
  • Compiling site regulatory documentation for Investigator Site Files, according to company SOPs or Sponsor PSOPs, and performing a Quality Check review of documents.
  • Assessing accuracy and completeness of Regulatory-Package for drug release.
  • Assisting Project Managers with needed documents for submission in other EU countries.
  • Assisting Study Teams, Project Managers, and Senior Director of Clinical Operations in all Regulatory requirements.
  • Checking requirement for IRB/IEC submissions (central and local) for e.g. timelines, needed copies of documentation, special requirements, and separate forms.
  • Tracking submissions to IRB/IEC and/or CA.
  • Assisting with training and mentoring of junior-level Regulatory staff.

Skills and Requirements:

  • A Bachelor's or Masters' degree in Pharmacy or Natural Science.
  • At least 3 years of Regulatory Affairs Experience from the Pharmaceutical, Biotech, or CRO industries.
  • A working knowledge and understanding of National Drug Laws of various EU countries and GCH/ICH regulations and guidelines.
  • Strong decision-making and creative problem-solving skills.
  • Strong understanding and application of principles, concepts, practices, and standards in Clinical Research.
  • Proficiency with MS Office.
  • Demonstrable collaboration, persuasion, and communication skills.
  • The capability to work under pressure.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 752 0314 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.