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CMC Documentation Manager
vor 1 Woche
Key Responsibilities:
As a Regulatory Affairs Manager at Lonza, your responsibilities will include authoring and reviewing Module 3.2 dossier sections, tracking and negotiating source document availability, and preparing responses to health authority submission review questions.
You will represent the Regulatory Affairs department in project teams, lead submission-related activities, and perform regulatory assessments for deviations, change controls, and VCNs to ensure compliance with internal procedures and regulations.
Requirements:
- A Master's degree in a relevant field. Higher education (PhD, PharmD) or Regulatory Affairs Certification (RAC) is preferred.
- At least 5 years of experience in preparing and authoring M.3.2 CMC dossier sections.
- Previous experience in a CMO/CDMO environment is advantageous.
- Extensive experience leading project teams to successful filings and approvals.
- Expertise in ICH guidelines and EU and US regulatory requirements for biologics.
- Knowledge of biologics manufacturing processes.
- Experience in QA, MSAT, Operations, Analytical Development, and Quality control functions is beneficial.
- Fluency in English and German is desirable.
