CMC Regulatory Affairs and PM Manager

Experienced CMC Regulatory Affairs Lead and Pharmaceutical Project Manager with over 20 years of experience in Pharmaceutical and Biotechnology Companies. Long experience working with teams to accomplish short- and long-term project goals, manage budgets and monitor project costs.

CMC Reagulatory AffairsManager: Experience in CTD (NDA, BLA, ANDA), modules 3.2.S, 3.2.P, compilation, review and management. Experience in IND and IMPD.

Experience in all activities related to requests for changes / renewals / extensions, subsequent to the registration phase.

Master in Project Management: responsible for planning, overseeing and leading projects, from ideation through to completion.

Experience in coordinating and supervising research and development activities, scale-up and processes technology transfer.

Member of PMI (Project Management Institute).

Certification in Regulatory Affairs: EU, US and RoW countries, such as China, Russia, Latin America, the Middle East and Japan, for Drug Products and APIs.

Member of RAPS (Regulatory Affairs Professionals Society).

Expertise in Quality Assurance: GMP audits to customers, self-inspections, qualification of supplies, internal training.

Support for the review of commercial contracts and quality agreements; preparation of offers and requests for proposals, review of contracts and exclusive agreements.

Experience in intellectual property management; successful filing of patents for finished product formulations.

Per maggiori informazioni e sul profilo, contattare la segreteria AFTI.