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