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Regulatory Affairs Manager

Regulatory Affairs Manager

CTCBasel and NW Switzerland, CH
Vor 18 Tagen
Stellenbeschreibung

Main Responsibilities :

  • Author and review CTD module 3.2 sections (drug substance / drug product) for biologicals medicinal products;
  • Prepare high-quality clinical trials applications, BLA / MAA, and post-approval submissions;
  • Manage timely responses to Health Authority (HA) questions;
  • Lead and coordinate activities to ensure submission deadlines are met;
  • Communicate and escalate risks and issues to management and project teams, as applicable;
  • Act as RA Point of Contact or RA team member for assigned projects;
  • Manage change Controls and Deviations;
  • Support site-specific regulatory documentation and activities.

Qualifications and Experience :

  • Relevant working / residency permit or Swiss / EU-Citizenship required;
  • A Bachelor’s or Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy or equivalent;
  • At least 5 years in authoring high-quality CMC CTD sections (content and format) for drug substance, drug product, and appendices from first-in-human to post-approval for biological medicinal products;
  • Good understanding of manufacturing processes and quality control for biological medicinal products;
  • Strong knowledge of CMC requirements for biologics as well as good procedural knowledge (EU and US; other markets is a plus);
  • Good CMC writing skills;
  • Previous experience in contractor environment e.g. CMO / CDMO, CRO, Consultancy is an advantage.