Regulatory Affairs Collaborator

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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