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

Details

Beschreibung

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)

Kontakt