Description
Wir, die Accessio IMS, suchen ab dem 01.05.2021 für unseren Kunden einen Freelancer Regulatory Compliance Consultant (m/f/d) für ca. 6 Monate mit Option auf Verlängerung am Standort Raum Darmstadt.Auslastung: 3 days per week
Projects:
o Preparation of Quality Reference Files before launch of the medicinal product (Primary project activity)
o Nitrosamine Risk Assessments for BOPPs; preparation of risk assessments, overview of submitted reports and planning of necessary testing
activities
o Evaluation, compliance check and gap analysis of a registration dossiers from external partners intended for in-licensing (Due Diligence).
o Support to answer deficiency letters from Health Authorities.
o Evaluation and reviewing of upcoming changes related to initial launches or initial proactive global harmonization of compliance status.
Competencies required:
o Operational / hands on CMC Writing experience (3-4 years) for Pharma products (generics a plus)
o Technical dossier expertise (eg. analytical / qualification) either leading or reviewing / participating in compliance gap analysis and closure
o Experience in regulatory registration processes for initial submission and maintenance activities (incl. in EU DCP/MRP, Latin America)
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