Regulatory Affairs Collaborator

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. Germany
Frankfurt am Main, Germany
Posting date: 27 Oct 2020
33812

Proclinical has partnered with a mirco-immunotheraphy company in search for a Regulatory Affairs Collaborator. You will oversee ensuring to dispose of the necessary regulatory dossiers in compliance to the regulations of the relevant authorities, of respecting deadlines.

Job Responsibilities

  • Collaborating to the elaboration of the local registration strategy
  • Communication with the health authorities (pre- and post-submission)
  • Adaptation, preparation and writing of the dossiers (module 1 to 5) according to the
    national guidelines
  • Maintenance of the dossiers up to date throughout their lifecycle (variations, renewal,
    changes in regulations, etc.)
  • Redaction and follow up questions/answers with health authorities
  • Submission of the eCTD format dossiers


Skills and Requirements

  • Professional experience (at least 3 years) in the regulatory affairs
    field for homeopathic human medicines with BfArM
  • You can analyse, interpret and use legal, regulatory, scientific and technical
    information.
  • Due to the specificity of micro-immunotherapy medicinal products, you are open-minded,
    creative and able to elaborate a strategy for registering our medicines in Germany.
  • You dispose of a very strong autonomy, you are organized, rigorous and persevering.
  • You are fluent in German and English, both in writing and speaking.

To Apply

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

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