Regulatory CMC Writer (d/m/f) – freelance – on hold

  • Position zu besetzen ab 1. April 2021
  • Permanent-ID OCR-FL-1259
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Tasks:

  • Preparation of Quality Reference Files before launch of the medicinal product (Primary project activity)
  • Nitrosamine Risk Assessments for BOPPs; preparation of risk assessments, overview of submitted reports and planning of necessary testing activities
  • Evaluation, compliance check and gap analysis of a registration dossiers from external partners intended for in-licensing (Due Diligence)
  • Support to answer deficiency letters from Health Authorities
  • Evaluation and reviewing of upcoming changes related to initial launches or initial proactive global harmonization of compliance status.

 

 

Qualification:

  • Operational / hands on CMC Writing experience (3-4 years) for Pharma products (generics a plus)
  • Technical dossier expertise (eg. analytical / qualification) either leading or reviewing / participating in compliance gap analysis and closure
  • Experience in regulatory registration processes for initial submission and maintenance activities (incl. in EU DCP/MRP, Latin America)

 

Additional Information

Location: Darmstadt (remote)

Project start: 01.04.2021, at the latest end of April

Duration: 7 months

Availability: 3-4 days/week

On-site: tbd.

Remote: 100% (during COVID-19)

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